Sorrells Tibia Protective Plate Small 65x40mm
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Sorrells Tibia Protective Plate Small 65x40mm EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Device Name
- Cover EUDAMEDSorrells Tibia Protective Plate Small 65x40mm FDA UDI
- Model / Reference
- 1135 EUDAMEDFDA UDI
- Description
- Sorrells Tibia Protective Plate Small 65x40mm FDA UDI
Identifiers
- Catalog Number
- 1135 FDA UDI
- Primary DI / UDI-DI
- 00840277100139 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNOCOV01KP EUDAMED
- Direct Marketing DI
- 00840277100139 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument guard, 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Sorrells Tibia Protective Plate Small 65x40mm is a medical device designed to provide a stable and secure platform for implantable devices, particularly orthopedic implants. This plate is made from high-quality materials and features advanced manufacturing techniques that ensure its strength and durability.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8402771INNOCOV01KP | 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 06312c16-ae2f-43d9-b85e-781898938d03 61 fields · synced Aug 3, 2026
- FDA UDI c6151a2f-c12f-45ed-8dbb-3640412eb615 34 fields · synced May 29, 2026