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Concept

EUDAMEDFDA UDI

Class I (EU MDR)

Ref C6850Ref CR8850Ref CR8901Ref CR8848Ref C6858Ref PS8822Ref C6869Ref CR8851Ref C6810Ref SMI-00DRef PS8823Ref D8626Ref PS8830Ref C6855Ref C6812Ref CR8849Ref PS8829Ref TS8850Ref TD8506.5Ref TD8508Ref TD8510.5Ref D8637Ref TD8512Ref TD8508.5Ref TD8506Ref TD8511.5

by Conmed Corporation

Identity

Trade Name
CONCEPT EUDAMEDFDA UDI
Concept Grafix EUDAMEDFDA UDI
Generic Name
Orthopaedic implant driver FDA UDI
Bone-resection orthopaedic reamer, reusable FDA UDI
Bone-coring punch, reusable FDA UDI
Bone-resection orthopaedic reamer, single-use FDA UDI
General-purpose surgical scissors, reusable FDA UDI
Tendon/ligament graft preparation station FDA UDI
Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
Bone tap, reusable FDA UDI
Surgical drill guide, reusable FDA UDI
Suturing needle, single-use FDA UDI
Device Name
Orthopedic, Non-active, Reusable Surgical Instrument, Punching EUDAMED
Orthopedic, Non-active, Reamer, Disposable, Coring EUDAMED
Orthopedic, Non-active, Reusable Surgical Instrument, Graft Preparation EUDAMED
Orthopedic, Non-active, Reusable Surgical Instrument, Cutting EUDAMED
Orthopedic, Non-active, Instrument, Suture Passer Needle, Concept EUDAMED
Orthopedic, Non-active, Reusable Surgical Instrument, Implant Insertion/Removal EUDAMED
Orthopedic, Non-active, Reusable Surgical Instrument, Passing/Retrieval EUDAMED
Reusable Manual Surgical Instruments EUDAMED
CONCEPT GRAFIX MODULAR 3.5 MM HEX DRIVER FDA UDI
CONCEPT GRAFIX CORING REAMER ADAPTER FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 6.5 MM FDA UDI
CONCEPT GRAFIX CORING REAMER 9 MM FDA UDI
CONCEPT ROTARY PUNCH, 90°, LEFT FDA UDI
CONCEPT LINEAR WIDE BITE PUNCH, STRAIGHT FDA UDI
CONCEPT GRAFIX CORING REAMER 11 MM FDA UDI
CONCEPT ROTARY SCISSOR, 20°, LEFT FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 11.5 MM FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 6.0 MM FDA UDI
Concept Grafix Suture Holder FDA UDI
CONCEPT LINEAR GRASPER, LARGE BODY FDA UDI
Concept Grafix Graft Preparation Board FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 10.5 MM FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 8.0 MM FDA UDI
CONCEPT LINEAR PUNCH, OBLIQUE, CURVED RIGHT FDA UDI
CONCEPT GRAFIX TENDON STRIPPER, 7.0 MM FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 8.5 MM FDA UDI
CONCEPT GRAFIX CORING REAMER 10 MM FDA UDI
CONCEPT GRAFIX MODULAR 7 MM BIOSCREW TAP FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 12.0 MM FDA UDI
CONCEPT GRAFIX CORING REAMER 8 MM FDA UDI
Concept Grafix Drill Guide FDA UDI
Concept Grafix Graft Clamp FDA UDI
CONCEPT SUTURE PASSER NEEDLE FDA UDI
CONCEPT 1.3 MM PUNCH, STRAIGHT FDA UDI
Model / Reference
C6850 EUDAMEDFDA UDI
CR8850 EUDAMEDFDA UDI
CR8901 EUDAMEDFDA UDI
CR8848 EUDAMEDFDA UDI
C6858 EUDAMEDFDA UDI
PS8822 EUDAMEDFDA UDI
C6869 EUDAMEDFDA UDI
CR8851 EUDAMEDFDA UDI
C6810 EUDAMEDFDA UDI
SMI-00D EUDAMED
PS8823 EUDAMEDFDA UDI
D8626 EUDAMEDFDA UDI
PS8830 EUDAMEDFDA UDI
C6855 EUDAMEDFDA UDI
C6812 EUDAMEDFDA UDI
CR8849 EUDAMEDFDA UDI
PS8829 EUDAMEDFDA UDI
TS8850 EUDAMEDFDA UDI
TD8506.5 EUDAMEDFDA UDI
TD8511.5 EUDAMEDFDA UDI
TD8506 EUDAMEDFDA UDI
TD8510.5 EUDAMEDFDA UDI
TD8508 EUDAMEDFDA UDI
TD8508.5 EUDAMEDFDA UDI
D8637 EUDAMEDFDA UDI
TD8512 EUDAMEDFDA UDI
00602026000 FDA UDI
Description
CONCEPT GRAFIX MODULAR 3.5 MM HEX DRIVER FDA UDI
CONCEPT GRAFIX CORING REAMER ADAPTER FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 6.5 MM FDA UDI
CONCEPT GRAFIX CORING REAMER 9 MM FDA UDI
CONCEPT ROTARY PUNCH, 90°, LEFT FDA UDI
CONCEPT LINEAR WIDE BITE PUNCH, STRAIGHT FDA UDI
CONCEPT GRAFIX CORING REAMER 11 MM FDA UDI
CONCEPT ROTARY SCISSOR, 20°, LEFT FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 11.5 MM FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 6.0 MM FDA UDI
Concept Grafix Suture Holder FDA UDI
CONCEPT LINEAR GRASPER, LARGE BODY FDA UDI
Concept Grafix Graft Preparation Board FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 10.5 MM FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 8.0 MM FDA UDI
CONCEPT LINEAR PUNCH, OBLIQUE, CURVED RIGHT FDA UDI
CONCEPT GRAFIX TENDON STRIPPER, 7.0 MM FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 8.5 MM FDA UDI
CONCEPT GRAFIX CORING REAMER 10 MM FDA UDI
CONCEPT GRAFIX MODULAR 7 MM BIOSCREW TAP FDA UDI
CONCEPT GRAFIX TUNNEL DILATOR 12.0 MM FDA UDI
CONCEPT GRAFIX CORING REAMER 8 MM FDA UDI
Concept Grafix Drill Guide FDA UDI
Concept Grafix Graft Clamp FDA UDI
CONCEPT SUTURE PASSER NEEDLE FDA UDI
CONCEPT 1.3 MM PUNCH, STRAIGHT FDA UDI

Identifiers

Catalog Number
D8626 FDA UDI
CR8901 FDA UDI
TD8506.5 FDA UDI
CR8849 FDA UDI
C6850 FDA UDI
C6855 FDA UDI
CR8851 FDA UDI
C6810 FDA UDI
TD8511.5 FDA UDI
TD8506 FDA UDI
PS8823 FDA UDI
C6812 FDA UDI
PS8830 FDA UDI
TD8510.5 FDA UDI
TD8508 FDA UDI
C6869 FDA UDI
TS8850 FDA UDI
TD8508.5 FDA UDI
CR8850 FDA UDI
D8637 FDA UDI
TD8512 FDA UDI
CR8848 FDA UDI
PS8829 FDA UDI
PS8822 FDA UDI
6020-260 FDA UDI
C6858 FDA UDI
Primary DI / UDI-DI
10845854031285 EUDAMEDFDA UDI
10845854021842 EUDAMEDFDA UDI
10845854034705 EUDAMEDFDA UDI
10845854017197 EUDAMEDFDA UDI
10845854031339 EUDAMEDFDA UDI
10845854028674 EUDAMEDFDA UDI
10845854031414 EUDAMEDFDA UDI
10845854020524 EUDAMEDFDA UDI
10845854031254 EUDAMEDFDA UDI
10845854018200 EUDAMEDFDA UDI
10845854036280 EUDAMEDFDA UDI
10845854034828 EUDAMEDFDA UDI
10845854036327 EUDAMEDFDA UDI
10845854031308 EUDAMEDFDA UDI
10845854031278 EUDAMEDFDA UDI
10845854021835 EUDAMEDFDA UDI
10845854036310 EUDAMEDFDA UDI
10845854018255 EUDAMEDFDA UDI
10845854040584 EUDAMEDFDA UDI
10845854028865 EUDAMEDFDA UDI
10845854032480 EUDAMEDFDA UDI
10845854032558 EUDAMEDFDA UDI
10845854032510 EUDAMEDFDA UDI
10845854032527 EUDAMEDFDA UDI
10845854034873 EUDAMEDFDA UDI
10845854032572 EUDAMEDFDA UDI
Basic UDI-DI
B-10845854031285 EUDAMED
B-10845854021842 EUDAMED
B-10845854034705 EUDAMED
B-10845854017197 EUDAMED
B-10845854031339 EUDAMED
B-10845854028674 EUDAMED
B-10845854031414 EUDAMED
B-10845854020524 EUDAMED
B-10845854031254 EUDAMED
B-10845854018200 EUDAMED
B-10845854036280 EUDAMED
B-10845854034828 EUDAMED
B-10845854036327 EUDAMED
B-10845854031308 EUDAMED
B-10845854031278 EUDAMED
B-10845854021835 EUDAMED
B-10845854036310 EUDAMED
B-10845854018255 EUDAMED
B-10845854040584 EUDAMED
B-10845854032510 EUDAMED
B-10845854032558 EUDAMED
B-10845854034873 EUDAMED
B-10845854032572 EUDAMED
B-10845854032527 EUDAMED
B-10845854032480 EUDAMED
B-10845854028865 EUDAMED
FDA Product Code
NBH FDA UDI
HTO FDA UDI
LXH FDA UDI
HWT FDA UDI
HWX FDA UDI
EMDN Code
L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE EUDAMED
L091106 INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE EUDAMED
P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
L091202 ORTHOPAEDIC SURGERY FILES, REUSABLE EUDAMED
H900899 SINGLE-USE INSTRUMENTS FOR SUTURES - OTHER EUDAMED
L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
GMDN Term
Orthopaedic implant driver FDA UDI
Bone-resection orthopaedic reamer, reusable FDA UDI
Bone-coring punch, reusable FDA UDI
Bone-resection orthopaedic reamer, single-use FDA UDI
General-purpose surgical scissors, reusable FDA UDI
Tendon/ligament graft preparation station FDA UDI
Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
Bone tap, reusable FDA UDI
Surgical drill guide, reusable FDA UDI
Suturing needle, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class IIa EUDAMED
Regulation Number
888.1100 FDA UDI
888.4540 FDA UDI
888.4800 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

No

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 6.5 Millimeter FDA UDI
Angle — 90 degree FDA UDI
Angle — 20 degree FDA UDI
Outer Diameter — 6 Millimeter FDA UDI

Concept by Conmed Corporation — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conmed Corporation
EUDAMED SRN
US-MF-000012663
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (70)

  • EUDAMED 13c9e7c6-0ca5-4be1-aee1-f72476bcec85 61 fields · synced Aug 4, 2026
  • EUDAMED 1d0c82ae-5d17-4793-8872-c73b28771e09 61 fields · synced May 16, 2026
  • EUDAMED 86d93baf-df44-4902-a99a-95ed05bb3e83 61 fields · synced May 16, 2026
  • EUDAMED 211a72b4-a034-40bd-b772-e32d50fe30c8 61 fields · synced May 16, 2026
  • EUDAMED db29749a-e77d-4db2-bb45-4ef672141adc 61 fields · synced May 16, 2026
  • EUDAMED 59a4c6d8-e8b6-4df3-9cd3-a2d8872521b5 61 fields · synced May 17, 2026
  • EUDAMED e78e830d-61bf-452e-b27e-d43d854afefd 61 fields · synced May 17, 2026
  • EUDAMED 7329f711-78d0-41a2-9ee3-fc09a9d1ee2f 61 fields · synced May 17, 2026
  • EUDAMED 413f2dc0-9b73-405d-ae5e-bf9164d53d1b 61 fields · synced May 17, 2026
  • EUDAMED 3825a840-116e-4a81-bb1e-7cad4c771c7a 61 fields · synced May 18, 2026
  • EUDAMED 81d61f8e-2e0c-42ec-a792-8ca9d724ee8f 61 fields · synced May 18, 2026
  • EUDAMED 9ad2e5c5-6d02-4b6f-8905-ecd86b7eb90e 61 fields · synced May 18, 2026
  • EUDAMED a51e4de4-be61-4dda-b3ac-7e8e2d268a10 61 fields · synced May 18, 2026
  • EUDAMED 0c1004f1-0850-4d74-a549-9957090d8f3d 61 fields · synced May 18, 2026
  • EUDAMED 7e6cf70d-3fac-4eea-bfa2-ef087db061bf 61 fields · synced May 18, 2026
  • EUDAMED deb12e80-a7dc-41a6-a213-36ff509727af 61 fields · synced May 18, 2026
  • EUDAMED 49b55c70-10c4-4070-bcb8-ae9c42db4b6f 61 fields · synced May 19, 2026
  • EUDAMED d88193fd-7647-4c8c-a314-1c813ed945cd 61 fields · synced May 19, 2026
  • FDA UDI b4dbf294-dc65-4b8d-9511-a287d88f65af 35 fields · synced May 27, 2026
  • FDA UDI 7a7fc751-c409-41ea-af86-d48414f468e4 35 fields · synced May 29, 2026
  • FDA UDI 95a404ad-55ea-4e45-8682-a7ca626a7b35 37 fields · synced May 29, 2026
  • FDA UDI fcc75738-de14-46c9-ab3e-6bda9a06cd99 35 fields · synced May 29, 2026
  • FDA UDI 917b8991-8e21-4aa5-8532-a083e2c3fcba 37 fields · synced May 29, 2026
  • FDA UDI 65bbc7a4-a68b-4093-bde7-889433a8c229 36 fields · synced May 30, 2026
  • FDA UDI 1d787b85-110a-48a6-a362-2102492086df 35 fields · synced May 30, 2026
  • FDA UDI 8423c4b5-640a-4a99-bdc9-8317565b5450 37 fields · synced May 30, 2026
  • FDA UDI 36e5f34c-1fd4-4273-a8aa-decd0912bc29 36 fields · synced May 30, 2026
  • FDA UDI 4a76e302-e2e4-423f-9b7e-604317a42b26 37 fields · synced May 30, 2026
  • FDA UDI 1ca05434-dfc1-4951-bd1d-7918d1c07492 36 fields · synced May 30, 2026
  • FDA UDI 6bbb812f-876d-4ae5-892a-9d810735641c 36 fields · synced May 30, 2026
  • FDA UDI d3b5bd37-4eaa-4955-8be8-0cb939538a8d 36 fields · synced May 30, 2026
  • FDA UDI a1d1a9e7-9a22-47de-be69-fd80dc2ac5da 36 fields · synced May 30, 2026
  • FDA UDI 8f5a1ede-1d89-47c9-a7ad-cca44686ad9b 36 fields · synced May 30, 2026
  • FDA UDI 69b68e30-8545-460a-8390-2f477b3411de 36 fields · synced May 30, 2026
  • FDA UDI fa3cb4e3-c0c4-4800-8283-77a437f7ac17 35 fields · synced May 30, 2026
  • FDA UDI 32f76f4a-9f7b-4b37-8857-8637c8d33d9d 36 fields · synced May 30, 2026
  • FDA UDI 1421aeaa-0860-453b-bf5f-7958b31c7aeb 35 fields · synced May 30, 2026
  • FDA UDI 7e01dad6-0b6e-47e9-a1f5-d0301f0484b7 35 fields · synced May 30, 2026
  • FDA UDI 00f369b3-43d0-4bd8-b3ff-d7977878d02e 36 fields · synced May 30, 2026
  • FDA UDI 08df9d4f-fbea-4249-ab09-9840c6c4ffe2 35 fields · synced May 30, 2026
  • FDA UDI 98154fda-7528-4b51-9323-0a90bf7042bc 36 fields · synced May 30, 2026
  • FDA UDI 1d72f714-2ddf-477e-8908-3eac338fbfb6 36 fields · synced May 30, 2026
  • FDA UDI e8ae538b-4f17-4471-be86-842cad4d3b61 36 fields · synced May 30, 2026
  • FDA UDI 6e58eadc-4ec6-4593-b8f5-5738797cc63a 37 fields · synced May 30, 2026
  • EUDAMED 0de54695-9ab0-4539-8403-402f2e2038d9 61 fields · synced Jun 20, 2026
  • EUDAMED 7877b9d0-fd9c-41a3-8ab8-dbfbb7023cf8 61 fields · synced Jul 9, 2026
  • EUDAMED 5c889e95-8a2f-4619-9722-ca727a3f7bd3 61 fields · synced Jul 9, 2026
  • EUDAMED fdeefe34-e2a2-4f37-8dc6-9df268f69732 61 fields · synced Jul 9, 2026
  • EUDAMED 976b1f69-acd8-4572-bacc-5c70e95cd8ea 61 fields · synced Jul 11, 2026
  • EUDAMED 21c92561-f52b-4fc7-804c-85185f3925c5 61 fields · synced Jul 12, 2026
  • EUDAMED 186e94e8-84cc-40cc-8a7b-f3b97487453a 61 fields · synced Jul 12, 2026
  • EUDAMED 0890527c-726d-4ad0-9bd1-7041b04ccfb7 61 fields · synced Jul 14, 2026
  • EUDAMED 35dab863-47e2-4db7-9990-f32fa55fe353 61 fields · synced Jul 15, 2026
  • EUDAMED b9f3e08c-b550-4c6e-96a3-c47c27c3b308 61 fields · synced Jul 16, 2026
  • EUDAMED a0f11f73-071f-410f-a784-7697bdd8d995 61 fields · synced Jul 17, 2026
  • EUDAMED 501c61a1-f92a-4f93-9a02-e77a9a7fec1c 61 fields · synced Jul 17, 2026
  • EUDAMED c3c26543-f32b-4bed-90ad-a9bad1852af1 61 fields · synced Jul 18, 2026
  • EUDAMED 3a3ba221-f0e6-4e8b-8d66-5cd5ca117253 61 fields · synced Jul 18, 2026
  • EUDAMED f64a1ac6-2097-46ae-baf8-58d969faf124 61 fields · synced Jul 19, 2026
  • EUDAMED d7e3aaf7-3487-4a08-82bb-800fbe032f07 61 fields · synced Jul 20, 2026
  • EUDAMED 81fa57c1-3b58-4b8b-b826-bf9f4743a175 61 fields · synced Jul 21, 2026
  • EUDAMED b2f7c80a-bbac-4e68-ba8e-18fc762f26ef 61 fields · synced Jul 21, 2026
  • EUDAMED 259bb78f-ce97-43dc-a3af-74708fb9d18b 61 fields · synced Jul 22, 2026
  • EUDAMED 8f3d125b-05a1-46d2-b299-6953d4f24275 61 fields · synced Jul 26, 2026
  • EUDAMED fa1fdc0d-c319-48b3-bf72-150b0fa0da2f 61 fields · synced Jul 27, 2026
  • EUDAMED 8a0618b0-8786-4cb5-8ab2-fdff338275b0 61 fields · synced Jul 29, 2026
  • EUDAMED 501533f2-82fe-40f7-b6f3-1d66cd78a9c0 61 fields · synced Aug 1, 2026
  • EUDAMED 4e99b816-0890-4d34-94de-8219ee75d8fb 61 fields · synced Aug 2, 2026
  • EUDAMED f118e3c3-1e52-4659-8d20-a2eb4856b6d6 61 fields · synced Aug 2, 2026
  • EUDAMED 64713839-1d61-4212-b451-b4e7bc932676 61 fields · synced Aug 4, 2026