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Gauthier Biomedical

EUDAMEDFDA UDI

Class I (EU MDR)

Ref G170402Ref G119402Ref G415163Ref G412162Ref G412161Ref G852404Ref G900000Ref 5161-00-5000Ref G207166Ref 5161-00-5030Ref G900037Ref 5161-00-5091Ref 254600410Ref 5161-00-5027Ref 5161-00-5052Ref AR-9091-37Model G207169Ref 5161-00-5010Ref 5161-00-5012Ref G851301

by Gauthier Biomedical, Inc.

Identity

Trade Name
GAUTHIER BIOMEDICAL EUDAMEDFDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Orthopaedic surgical distractor, external FDA UDI
Surgical instrument handle, torque-limiting FDA UDI
Orthopaedic implant driver FDA UDI
Manual orthopaedic bender, reusable FDA UDI
Bone awl, reusable FDA UDI
Device Name
PALM HANDLE, RATCHET, SMALL TRI FLAT EUDAMED
MINI T HANDLE, RATCHET, SMALL TRI FLAT EUDAMED
OFFSET T HANDLE, TORQUE LIMITER, 12 Nm EUDAMED
BALANCED T HANDLE, TORQUE LIMITER, 8 Nm EUDAMED
BALANCED T HANDLE, TORQUE LIMITER, 12 Nm EUDAMED
MINI INLINE HANDLE, RATCHET EUDAMED
INLINE HANDLE, RATCHET EUDAMED
AWL EUDAMEDFDA UDI
"INLINE TORQUE ADAPTER, HALL JACOBS SHAFT, 10 mm HEX SOCKET, 35 IN LBS (3,95 Nm) " EUDAMED
ROD PUSHER 5,5/6,0 EUDAMED
INLINE HANDLE, RATCHET, SMALL HUDSON PULL COLLAR EUDAMED
T HANDLE, LOW TORQUE WRENCH EUDAMED
CORONAL BENDER 5,5, LEFT EUDAMED
DISTRACTOR 5,5/6,0, PARALLEL EUDAMED
INLINE TORQUE LIMITING ADAPTER, 3,2 Nm EUDAMED
T HANDLE, RATCHET EUDAMED
PALM HANDLE, RATCHET EUDAMED
MINI T HANDLE, RATCHET EUDAMED
MINI T HANDLE, RATCHETING FDA UDI
MINI INLINE HANDLE, RATCHETING FDA UDI
DISTRACTOR 5.5/6.0, PARALLEL FDA UDI
Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 8Nm FDA UDI
Multi-Color Inline Ratcheting Handle FDA UDI
ROD PUSHER 5.5/6.0 FDA UDI
G10 LARGE INLINE RATCHETING HANDLE, SMALL HUDSON PULL COLLAR FDA UDI
INLINE TORQUE ADAPTER, HALL JACOBS SHAFT, 10mm HEX SOCKET, 35 in lbs (3,95 Nm) (Smith & Nephew # 71094104 - MAVERICK (TM) Afterburner 10 mm ) FDA UDI
Low Torque T-Handle (Distributor Part Number 254600410) FDA UDI
MINI T HANDLE, RATCHETING, SMALL TRI FLAT FDA UDI
PALM HANDLE, RATCHETING FDA UDI
T HANDLE, RATCHETING FDA UDI
PALM HANDLE, RATCHETING, SMALL TRI FLAT FDA UDI
CORONAL BENDER 5.5, LEFT FDA UDI
Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 12Nm FDA UDI
Offset T-Torque, 1 / 4 inch (6,35mm) Square, 12Nm FDA UDI
Model / Reference
G170402 EUDAMEDFDA UDI
G119402 EUDAMEDFDA UDI
G415163 EUDAMEDFDA UDI
G412162 EUDAMEDFDA UDI
G412161 EUDAMEDFDA UDI
G852404 EUDAMEDFDA UDI
G900000 EUDAMEDFDA UDI
5161-00-5000 EUDAMED
G851301 EUDAMEDFDA UDI
G900037 EUDAMEDFDA UDI
G207166 EUDAMEDFDA UDI
254600410 EUDAMEDFDA UDI
5161-00-5030 EUDAMED
5161-00-5091 EUDAMED
5161-00-5027 EUDAMED
5161-00-5052 EUDAMED
G207169 EUDAMED
AR-9091-37 EUDAMED
5161-00-5010 EUDAMED
5161-00-5012 EUDAMED
5161-00-5091 (G901021) FDA UDI
5161-00-5052 (G602227) FDA UDI
5161-00-5030 (GC101061) FDA UDI
5161-00-5012 (G912118) FDA UDI
5161-00-5010 (G914562) FDA UDI
5161-00-5027 (GC155010-20) FDA UDI
5161-00-5000 (G908179) FDA UDI
Description
MINI T HANDLE, RATCHETING FDA UDI
MINI INLINE HANDLE, RATCHETING FDA UDI
DISTRACTOR 5.5/6.0, PARALLEL FDA UDI
Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 8Nm FDA UDI
Multi-Color Inline Ratcheting Handle FDA UDI
ROD PUSHER 5.5/6.0 FDA UDI
G10 LARGE INLINE RATCHETING HANDLE, SMALL HUDSON PULL COLLAR FDA UDI
INLINE TORQUE ADAPTER, HALL JACOBS SHAFT, 10mm HEX SOCKET, 35 in lbs (3,95 Nm) (Smith & Nephew # 71094104 - MAVERICK (TM) Afterburner 10 mm ) FDA UDI
Low Torque T-Handle (Distributor Part Number 254600410) FDA UDI
MINI T HANDLE, RATCHETING, SMALL TRI FLAT FDA UDI
PALM HANDLE, RATCHETING FDA UDI
T HANDLE, RATCHETING FDA UDI
PALM HANDLE, RATCHETING, SMALL TRI FLAT FDA UDI
CORONAL BENDER 5.5, LEFT FDA UDI
Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 12Nm FDA UDI
AWL FDA UDI
Offset T-Torque, 1 / 4 inch (6,35mm) Square, 12Nm FDA UDI

Identifiers

Catalog Number
G851301 FDA UDI
5161005091 FDA UDI
5161005052 FDA UDI
G412162 FDA UDI
G900000 FDA UDI
5161005030 FDA UDI
G900037 FDA UDI
71094104 FDA UDI
G140553 FDA UDI
G852404 FDA UDI
G119402 FDA UDI
5161005012 FDA UDI
5161005010 FDA UDI
G170402 FDA UDI
5161005027 FDA UDI
G412161 FDA UDI
5161005000 FDA UDI
G415163 FDA UDI
Primary DI / UDI-DI
00858325005794 EUDAMEDFDA UDI
00858325005787 EUDAMEDFDA UDI
00858325005237 EUDAMEDFDA UDI
00858325005220 EUDAMEDFDA UDI
00858325005213 EUDAMEDFDA UDI
00858325005770 EUDAMEDFDA UDI
00858325005008 EUDAMEDFDA UDI
00858325005428 EUDAMEDFDA UDI
00858325005763 EUDAMEDFDA UDI
00858325005558 EUDAMEDFDA UDI
00858325005701 EUDAMEDFDA UDI
00858325005664 EUDAMEDFDA UDI
00858325005374 EUDAMEDFDA UDI
00858325005398 EUDAMEDFDA UDI
00858325005169 EUDAMEDFDA UDI
00858325005503 EUDAMEDFDA UDI
00858325005480 EUDAMEDFDA UDI
00858325005633 EUDAMEDFDA UDI
00858325005732 EUDAMED
Basic UDI-DI
B-00858325005794 EUDAMED
B-00858325005787 EUDAMED
B-00858325005237 EUDAMED
B-00858325005220 EUDAMED
B-00858325005213 EUDAMED
B-00858325005770 EUDAMED
B-00858325005008 EUDAMED
008583250055161-00-5000PP EUDAMED
B-00858325005398 EUDAMED
008583250055161-00-5030PY EUDAMED
B-00858325005374 EUDAMED
008583250055161-00-5091QL EUDAMED
00858325005G119402AS EUDAMED
00858325005G852404DL EUDAMED
B-00858325005169 EUDAMED
008583250055161-00-5027QB EUDAMED
00858325005G170402AV EUDAMED
00858325005G412162AK EUDAMED
008583250055161-00-5052QA EUDAMED
00858325005G415163BA EUDAMED
00858325005G412161AH EUDAMED
00858325005AR-9091-37DP EUDAMED
008583250055161-00-5010PS EUDAMED
008583250055161-00-5012PW EUDAMED
00858325005G851301D2 EUDAMED
Direct Marketing DI
00858325005428 EUDAMED
00858325005664 EUDAMED
00858325005558 EUDAMED
00858325005787 EUDAMED
00858325005770 EUDAMED
00858325005633 EUDAMED
00858325005794 EUDAMED
00858325005220 EUDAMED
00858325005701 EUDAMED
00858325005237 EUDAMED
00858325005213 EUDAMED
00858325005732 EUDAMED
00858325005480 EUDAMED
00858325005503 EUDAMED
00858325005763 EUDAMED
FDA Product Code
LXH FDA UDI
HWN FDA UDI
HWR FDA UDI
HXW FDA UDI
HWJ FDA UDI
EMDN Code
L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI
Orthopaedic surgical distractor, external FDA UDI
Surgical instrument handle, torque-limiting FDA UDI
Orthopaedic implant driver FDA UDI
Manual orthopaedic bender, reusable FDA UDI
Bone awl, reusable FDA UDI

Classification

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

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMEDEUDAMED

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 UDI

Manufacturing Date

Yes

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

Gauthier Biomedical by Gauthier Biomedical, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gauthier Biomedical, Inc.
EUDAMED SRN
US-MF-000015766
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (44)

  • EUDAMED 2a9db7f5-1421-464f-a4d6-41e382864599 61 fields · synced Aug 4, 2026
  • EUDAMED d9d2a49a-1867-4f92-98ae-e96a80f8ebd8 61 fields · synced May 16, 2026
  • EUDAMED ae2972f7-270c-47b9-b111-782d5d686eff 61 fields · synced May 17, 2026
  • EUDAMED 7ddcdac4-19af-4beb-9964-8181cd610c29 61 fields · synced May 18, 2026
  • EUDAMED 344c3146-44f5-488f-9fd9-562d3206328e 61 fields · synced May 18, 2026
  • EUDAMED 367edf6c-05e8-4a78-8e62-8990c9999608 61 fields · synced May 18, 2026
  • EUDAMED e93e13f0-edff-4c89-a3e2-a824b27a1638 61 fields · synced May 18, 2026
  • EUDAMED 8a327f05-79e7-43d7-9d16-95a0ec8e54d0 61 fields · synced May 18, 2026
  • FDA UDI fd53081f-3a6e-4433-bc33-e093d5d64ccd 36 fields · synced May 29, 2026
  • FDA UDI 76f40d20-f4f4-4d31-81f0-91a286964b27 35 fields · synced May 29, 2026
  • FDA UDI d81b5f7e-0ebe-4467-a4ce-de1da2c4dd0d 35 fields · synced May 29, 2026
  • FDA UDI 61243980-9aeb-4c03-b606-efa65050b072 35 fields · synced May 30, 2026
  • FDA UDI eb48e94b-595f-4977-a887-517d500921ee 35 fields · synced May 30, 2026
  • FDA UDI 5142e04c-0b00-4bef-aa54-e2bbb2b37268 35 fields · synced May 30, 2026
  • FDA UDI ede95246-3c65-428a-ae57-1be8505fdec1 34 fields · synced May 30, 2026
  • FDA UDI bf549434-505f-49a7-b1ff-fcaeb915e897 35 fields · synced May 30, 2026
  • FDA UDI 242d3800-9fb5-498d-917a-3837ffa2e6d2 35 fields · synced May 30, 2026
  • FDA UDI a7bd2dc8-130e-4ba3-92cc-1fc0bfc05d25 36 fields · synced May 30, 2026
  • FDA UDI f2c293b2-7b48-4220-8bcb-5625cd60abce 36 fields · synced May 30, 2026
  • FDA UDI d4d151a6-69ec-48dc-8bbe-b3c48e58548b 35 fields · synced May 30, 2026
  • FDA UDI c8536806-b840-4268-a2f2-f6073d092693 35 fields · synced May 30, 2026
  • FDA UDI 434e16ee-2ed6-446c-9c10-e46a341043ad 36 fields · synced May 30, 2026
  • FDA UDI bfcfff4c-bdce-4cff-ab12-f2679f2a8660 35 fields · synced May 30, 2026
  • FDA UDI 05051f54-b7cd-43fc-99e8-626bffba350c 35 fields · synced May 30, 2026
  • FDA UDI 78191940-6e68-45b8-a1e3-e7f5f6d2e42d 35 fields · synced May 30, 2026
  • FDA UDI 0ac8fb31-9e96-44e5-bea2-5d34e48eebf3 35 fields · synced May 30, 2026
  • EUDAMED c6ad4599-7fd6-4ce3-a5cd-e779a45b9726 61 fields · synced Jul 8, 2026
  • EUDAMED 083e662b-2720-4f52-a92d-a20b8b6bccde 61 fields · synced Jul 9, 2026
  • EUDAMED a397c2cb-ef99-4a45-a2e7-6b7c54ec4681 61 fields · synced Jul 11, 2026
  • EUDAMED ff8c5e09-0bb4-4e9a-aefa-078e608a5a85 61 fields · synced Jul 11, 2026
  • EUDAMED 52e592b8-bd84-42ed-b63d-fe11d77b1826 61 fields · synced Jul 11, 2026
  • EUDAMED beb30390-d77a-489e-98dd-5ce1a609e560 61 fields · synced Jul 11, 2026
  • EUDAMED a70bcc8f-dfcd-4f87-b038-3d5a3327991c 61 fields · synced Jul 13, 2026
  • EUDAMED aa7dc3c3-2c42-43ea-a647-bb9e00d9d885 61 fields · synced Jul 14, 2026
  • EUDAMED f0f57cbb-40a1-489b-bc05-c72fb9597362 61 fields · synced Jul 14, 2026
  • EUDAMED afcd894d-3ab4-4048-bbbe-46535d4dff3b 61 fields · synced Jul 15, 2026
  • EUDAMED 90214945-0f84-406b-a518-435651f19fee 61 fields · synced Jul 17, 2026
  • EUDAMED 3c3a256c-83cd-4c3d-95a7-ce7bcf445f17 61 fields · synced Jul 21, 2026
  • EUDAMED 61fcf441-c2a2-414f-b3e0-56924baf7c1e 61 fields · synced Jul 25, 2026
  • EUDAMED 30899e34-0097-4d09-b164-9363cbdc678a 61 fields · synced Jul 25, 2026
  • EUDAMED 69412335-3463-4bf5-b15f-a55d8068fbc0 61 fields · synced Jul 29, 2026
  • EUDAMED 694dfeed-f702-44df-9358-9982f4e849b1 61 fields · synced Jul 30, 2026
  • EUDAMED 7ab21e23-9060-4b9d-9560-3ab2688628d4 61 fields · synced Jul 30, 2026
  • EUDAMED bd4bc7a0-6600-4cba-9877-c183827bfb03 61 fields · synced Aug 4, 2026