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Offset Osteotome Blade 15mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref S1010Ref 1999-MOD-01
Identity
- Trade Name
- Offset Osteotome Blade 15mm EUDAMEDAlfred Retractor EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- Osteotome EUDAMEDRetractor EUDAMEDOffset Osteotome Blade 15mm FDA UDI
- Model / Reference
- S1010 EUDAMED1999-MOD-01 EUDAMEDFDA UDI
- Description
- Offset Osteotome Blade 15mm FDA UDI
Identifiers
- Catalog Number
- 1999-MOD-01 FDA UDI
- Primary DI / UDI-DI
- 00840277131614 EUDAMEDFDA UDI00840277131607 EUDAMED
- Basic UDI-DI
- 8402771INNOOSTEO016V EUDAMED8402771INNORETRACT016A EUDAMED
- Direct Marketing DI
- 00840277131614 EUDAMED00840277131607 EUDAMED
- FDA Product Code
- HWM FDA UDI
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMEDL0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic osteotome 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
Offset Osteotome Blade 15mm 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 | 8402771INNOOSTEO016V | 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 (3)
- EUDAMED 62ea383e-52b6-49a4-a6fe-09069172e651 61 fields · synced Jul 20, 2026
- EUDAMED 652a812c-6158-4bfb-802c-edc4ab069749 61 fields · synced May 18, 2026
- FDA UDI 9beaf2bd-f1c9-4adf-a93e-3d0d87df83d9 34 fields · synced May 30, 2026