Identity
- Trade Name
- GATOR, MERLIN EUDAMEDFDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Shaver Blade, Merlin Pre-Bent EUDAMEDMERLIN 15° GATOR, BENDABLE TO 30°, 3.7MM FDA UDI
- Model / Reference
- 37GTR-ME-PB EUDAMEDFDA UDI
- Description
- MERLIN 15° GATOR, BENDABLE TO 30°, 3.7MM FDA UDI
Identifiers
- Catalog Number
- 37GTR-ME-PB FDA UDI
- Primary DI / UDI-DI
- 10845854029442 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854029442 EUDAMED
- FDA Product Code
- GFA FDA UDI
- EMDN Code
- K030203 ARTHROSCOPY BLADES, SINGLE-USE EUDAMED
- GMDN Term
- Arthroscopic shaver system blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 15 degree FDA UDIAngle — 30 degree FDA UDIOuter Diameter — 3.7 Millimeter FDA UDI
Category: Arthroscopic shaver system blade, single-use
Gator, Merlin by Conmed Corporation — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI 993d3d9b-9b01-4d56-b48c-ad117817e821 37 fields · synced Jun 19, 2026
- EUDAMED 2107579d-3315-4525-ae69-dacfb8b56fa3 61 fields · synced Jun 19, 2026