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Starter/Finisher 78mm Blade Contour Template
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5200-78G
Identity
- Trade Name
- Starter/Finisher 78mm Blade Contour Template EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Extractor EUDAMEDStarter/Finisher 78mm Blade Contour Template FDA UDI
- Model / Reference
- 5200-78G EUDAMEDFDA UDI
- Description
- Starter/Finisher 78mm Blade Contour Template FDA UDI
Identifiers
- Catalog Number
- 5200-78G FDA UDI
- Primary DI / UDI-DI
- 00840277120472 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOEXTRACT0188 EUDAMED
- Direct Marketing DI
- 00840277120472 EUDAMED
- FDA Product Code
- HWB FDA UDI
- EMDN Code
- L0921 NON-IMPLANTABLE ORTHOPAEDIC DEVICES EXTRACTORS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- 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
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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Starter/Finisher 78mm Blade Contour Template by Innomed, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8402771INNOEXTRACT0188 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 9bc24eb4-deff-41df-949e-aa53e0011c8f 61 fields · synced Jul 9, 2026
- FDA UDI b72cfc21-2c0b-4b26-b233-a689c2280a1e 34 fields · synced May 29, 2026