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Restore
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 219314Model General Orthopedic Use Awls, Taps, and Reamers
Identity
- Trade Name
- RESTORE TIBIAL AWL ROUND EUDAMEDRESTORE FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Awl, Tap, Reamer, Femoral, Tibial, Cortical, Arthroscopic, Healix, Healix Advance, GII, Gryphon, Milagro EUDAMEDRESTORE TIBIAL AWL ROUND 90 Degrees FDA UDI
- Model / Reference
- 219314 EUDAMEDFDA UDIGeneral Orthopedic Use Awls, Taps, and Reamers EUDAMED
- Description
- RESTORE TIBIAL AWL ROUND 90 Degrees FDA UDI
Identifiers
- Catalog Number
- 219314 FDA UDI
- Primary DI / UDI-DI
- 10886705005697 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00121K4 EUDAMED
- Direct Marketing DI
- 10886705005697 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone awl, reusable
Restore by Medos International Sàrl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone awl, reusable.
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- Awl — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- CONMED — Conmed Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (2)
- FDA UDI 6c670510-fc95-4dc7-aad4-c816c60cc66b 35 fields · synced Jul 26, 2026
- EUDAMED 6377ab3e-acd6-4805-b791-69c75b56e8db 61 fields · synced Jul 26, 2026