Identity
- Trade Name
- 13mm x 8mm Impactor Tip Oval Steel EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- Impactor EUDAMED13mm x 8mm Impactor Tip Oval Steel FDA UDI
- Model / Reference
- 5370-02 EUDAMEDFDA UDI
- Description
- 13mm x 8mm Impactor Tip Oval Steel FDA UDI
Identifiers
- Catalog Number
- 5370-02 FDA UDI
- Primary DI / UDI-DI
- 00840277111548 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOIMPACT01T2 EUDAMED
- Direct Marketing DI
- 00840277111548 EUDAMED
- FDA Product Code
- HWA FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implant impactor, 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
13mm x 8mm Impactor Tip Oval Steel 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 | 8402771INNOIMPACT01T2 | 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 16be7d75-4ac2-4df1-9b51-8e43e81d1a93 61 fields · synced Jun 18, 2026
- FDA UDI 5cf882e5-5a26-48b8-ba79-a15179fbf784 34 fields · synced May 30, 2026