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DetachaTip
EUDAMEDFDA 510(k)FDA UDIClass IIb (EU MDR)
Ref 3-1018Ref 3-1004Ref 3-1008Ref 2-4307Ref 3-4306Ref 2-4319Ref 3-1010Ref 3-1003Ref 3-4312510(k) K092414Ref 3-1011Ref 3-4305Ref 3-4319
Identity
- Trade Name
- DetachaTip EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDIElectrosurgical handpiece, reusable FDA UDI
- Device Name
- Non-orthopedic, Active, Instrument, Electrosurgical, Handle and Interchangeable Instrument EUDAMEDDetachaTip III Shaft, Multiple Use Grasper, Babcock, 5 mm x 43 cm FDA UDIDETACHATIP III SHAFT, 5MM X 33CM MULTIPLE USE GRASPER, CLAW FDA UDIDetachaTip Shaft, Multiple Use Grasper, Allis, 5 mm x 43 cm FDA UDIDetachaTip III Shaft, Multiple Use Grasper, Straight Fenestrated (Duckbill), 5 mm x 33 cm FDA UDIDetachaTip III Shaft, Multiple Use Grasper, Allis, 5 mm x 43 cm FDA UDIDetachaTip III Shaft, Multiple Use Scissors, Curved Metzenbaum, 5 mm x 33 cm FDA UDIDetachaTip III Handle, Multiple Use Handle, Standard with Ratchet FDA UDIDetachaTip Shaft, Multiple Use Grasper, Straight Fenestrated (Duckbill), 5 mm x 43 cm FDA UDIDetachaTip III Shaft, Multiple Use Dissector, Tapered (Dolphin), 5 mm x 33 cm FDA UDIDetachaTip III Shaft, Multiple Use Grasper, Straight Long Fenestrated, 5 mm x 43 cm FDA UDIDetachaTip III Shaft, Multiple Use Scissors, Curved Mini-Metzenbaum, 5 mm x 33 cm FDA UDIDetachaTip III Shaft, Multiple Use Dissector, Blunt, 5 mm x 43 cm FDA UDI
- Model / Reference
- 3-1018 EUDAMEDFDA UDI3-1004 EUDAMEDFDA UDI3-1008 EUDAMEDFDA UDI2-4307 EUDAMEDFDA UDI3-4306 EUDAMEDFDA UDI2-4319 EUDAMEDFDA UDI3-1010 EUDAMEDFDA UDI3-1003 EUDAMEDFDA UDI3-4312 EUDAMEDFDA UDI3-4305 EUDAMEDFDA UDI3-1011 EUDAMEDFDA UDI3-4319 EUDAMEDFDA UDI
- Description
- DetachaTip III Shaft, Multiple Use Grasper, Babcock, 5 mm x 43 cm FDA UDIDETACHATIP III SHAFT, 5MM X 33CM MULTIPLE USE GRASPER, CLAW FDA UDIDetachaTip Shaft, Multiple Use Grasper, Allis, 5 mm x 43 cm FDA UDIDetachaTip III Shaft, Multiple Use Grasper, Straight Fenestrated (Duckbill), 5 mm x 33 cm FDA UDIDetachaTip III Shaft, Multiple Use Grasper, Allis, 5 mm x 43 cm FDA UDIDetachaTip III Shaft, Multiple Use Scissors, Curved Metzenbaum, 5 mm x 33 cm FDA UDIDetachaTip III Handle, Multiple Use Handle, Standard with Ratchet FDA UDIDetachaTip Shaft, Multiple Use Grasper, Straight Fenestrated (Duckbill), 5 mm x 43 cm FDA UDIDetachaTip III Shaft, Multiple Use Dissector, Tapered (Dolphin), 5 mm x 33 cm FDA UDIDetachaTip III Shaft, Multiple Use Grasper, Straight Long Fenestrated, 5 mm x 43 cm FDA UDIDetachaTip III Shaft, Multiple Use Scissors, Curved Mini-Metzenbaum, 5 mm x 33 cm FDA UDIDetachaTip III Shaft, Multiple Use Dissector, Blunt, 5 mm x 43 cm FDA UDI
Identifiers
- Catalog Number
- 3-4305 FDA UDI3-1011 FDA UDI2-4319 FDA UDI3-1008 FDA UDI3-4319 FDA UDI3-1003 FDA UDI3-1010 FDA UDI2-4307 FDA UDI3-1018 FDA UDI3-4306 FDA UDI3-1004 FDA UDI3-4312 FDA UDI
- Primary DI / UDI-DI
- 30653405061643 EUDAMEDFDA UDI30653405061544 EUDAMEDFDA UDI30653405061575 EUDAMEDFDA UDI30653405059459 EUDAMEDFDA UDI30653405061704 EUDAMEDFDA UDI30653405059497 EUDAMEDFDA UDI30653405061599 EUDAMEDFDA UDI30653405061537 EUDAMEDFDA UDI30653405061742 EUDAMEDFDA UDI30653405061698 EUDAMEDFDA UDI30653405061605 EUDAMEDFDA UDI30653405061773 EUDAMEDFDA UDI
- Basic UDI-DI
- B-30653405061643 EUDAMEDB-30653405061544 EUDAMEDB-30653405061575 EUDAMEDB-30653405059459 EUDAMEDB-30653405061704 EUDAMEDB-30653405059497 EUDAMEDB-30653405061599 EUDAMEDB-30653405061537 EUDAMEDB-30653405061742 EUDAMEDB-30653405061605 EUDAMEDB-30653405061698 EUDAMEDB-30653405061773 EUDAMED
- FDA Product Code
- KCT FDA 510(k)GEI FDA UDI
- EMDN Code
- L180602 ENDOSCOPIC ELECTROSURGERY ELECTRODES, REUSABLE EUDAMEDL180302 ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDIElectrosurgical handpiece, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 43 Centimeter FDA UDIWidth — 5 Millimeter FDA UDILength — 33 Centimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDI
DetachaTip by Conmed Corporation — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092414 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-30653405061643 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (34)
- EUDAMED 1ee74507-ef35-4ea8-bedf-1834094e70bb 61 fields · synced Jul 30, 2026
- EUDAMED 1cfa9a72-9dc7-4402-901f-6cce2648e1ba 61 fields · synced May 16, 2026
- EUDAMED f430d769-3c23-4f63-af3d-2e6de18fe795 61 fields · synced May 16, 2026
- EUDAMED e58e3bc6-7dac-4ea4-bb8a-c1a0dc1ebb2b 61 fields · synced May 17, 2026
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- EUDAMED 717ee120-057a-4f20-a314-77cbf4eee040 61 fields · synced May 18, 2026
- EUDAMED f95e0ac4-ebc6-4f0c-8939-a26759b2ce1f 61 fields · synced May 18, 2026
- EUDAMED dce6d315-6e34-4bf8-b23b-2baa1fa6b76e 61 fields · synced May 18, 2026
- EUDAMED 27ee8088-4d5c-4555-ab5e-9525b43be1f3 61 fields · synced May 18, 2026
- FDA 510(k) K092414 24 fields · synced May 18, 2026
- FDA UDI 6d95f0e3-7da7-4c21-ace4-fc888a572543 38 fields · synced May 29, 2026
- FDA UDI ec6cb56d-7d02-4b94-a4b5-0682a78efbbb 38 fields · synced May 29, 2026
- FDA UDI ec3cf2f3-5880-43f0-b9bc-2194f84d67a0 38 fields · synced May 30, 2026
- FDA UDI 14e905f4-beaf-44ed-b827-d44e178e7ace 38 fields · synced May 30, 2026
- FDA UDI 84d35e48-2395-42c6-9a5d-661ba03b0ab6 38 fields · synced May 30, 2026
- FDA UDI 4bb42e62-a7f3-4edc-9160-7ee9f0ca1c8b 38 fields · synced May 30, 2026
- FDA UDI 8a558afe-b331-4afa-b1a1-9efd46320085 37 fields · synced May 30, 2026
- FDA UDI 491d5553-16cd-4bf0-bfde-b77a97129aad 38 fields · synced May 30, 2026
- FDA UDI 4eeccf03-747d-4f11-9bb5-ee3044f57168 38 fields · synced May 30, 2026
- FDA UDI ba8d92ad-e45c-4a93-99c1-e56e872fd930 38 fields · synced May 30, 2026
- FDA UDI 19feeed1-ce6e-4ba3-b0ab-df11b01ca317 38 fields · synced May 30, 2026
- FDA UDI 9ad3097a-6b74-4fd8-a969-7ff85df82044 38 fields · synced May 30, 2026
- EUDAMED 32dd4d1b-7c1e-44c6-8a0a-d92acc94bbf8 61 fields · synced Jun 20, 2026
- EUDAMED b3f19c48-44e7-43fb-b081-01593c5387c0 61 fields · synced Jul 12, 2026
- EUDAMED 3f9e9da4-dfa9-4499-910a-445c1110578f 61 fields · synced Jul 12, 2026
- EUDAMED 8e586e81-beb3-4142-adf0-0059bc3c6e34 61 fields · synced Jul 14, 2026
- EUDAMED 6f2523d6-83f6-47f0-b9e6-dbb1ec8e0fe7 61 fields · synced Jul 16, 2026
- EUDAMED 73bcedf4-e5b7-4de8-8774-5e46df2af57e 61 fields · synced Jul 17, 2026
- EUDAMED 549a01a9-b22f-4ccd-b6ae-da1f2e03d3ca 61 fields · synced Jul 18, 2026
- EUDAMED f1ce7da3-0548-4c17-b85b-ed5469193931 61 fields · synced Jul 20, 2026
- EUDAMED 8948b635-8c91-4fbb-9be4-fe8eb3545d6d 61 fields · synced Jul 21, 2026
- EUDAMED 8ee0cbff-9edc-436b-b152-d7580f529cab 61 fields · synced Jul 22, 2026
- EUDAMED 9d067cf0-2e71-44d0-ad41-162dab42230c 61 fields · synced Jul 27, 2026
- EUDAMED 9749192d-e9d4-477b-b9f7-93b9c121c2bc 61 fields · synced Jul 30, 2026