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Delrin Head Replacement with 0.500" Stud Single
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7832-Head01
Identity
- Trade Name
- Delrin Head Replacement with 0.500" Stud Single EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Guide EUDAMEDDelrin Head Replacement with 0.500" Stud Single FDA UDI
- Model / Reference
- 7832-Head01 EUDAMEDFDA UDI
- Description
- Delrin Head Replacement with 0.500" Stud Single FDA UDI
Identifiers
- Catalog Number
- 7832-Head01 FDA UDI
- Primary DI / UDI-DI
- 00840277123237 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOGUIDE01VS EUDAMED
- Direct Marketing DI
- 00840277123237 EUDAMED
- FDA Product Code
- FZY FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Surgical mallet FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Delrin Head Replacement with 0.500" Stud Single 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 | 8402771INNOGUIDE01VS | 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 6fbe112e-f7dc-43a1-93b5-548cc3b42951 61 fields · synced Jul 10, 2026
- FDA UDI 9943ae74-bd5f-4b4b-b2ea-1b712e1497af 34 fields · synced May 29, 2026