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Restore
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 219311Model General Orthopedic Use Gouges
Identity
- Trade Name
- RESTORE GRAFT HARVEST GOUGE EUDAMEDRESTORE FDA UDI
- Generic Name
- Surgical gouge FDA UDI
- Device Name
- Gouge, Arthroscopic, Graft Harvest, RESTORE EUDAMEDRESTORE GRAFT HARVEST GOUGE FDA UDI
- Model / Reference
- 219311 EUDAMEDFDA UDIGeneral Orthopedic Use Gouges EUDAMED
- Description
- RESTORE GRAFT HARVEST GOUGE FDA UDI
Identifiers
- Catalog Number
- 219311 FDA UDI
- Primary DI / UDI-DI
- 10886705005666 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00124KA EUDAMED
- Direct Marketing DI
- 10886705005666 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical gouge FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1100 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: Surgical gouge
Restore by Medos International Sàrl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 658101c1-e4e3-4472-b972-a43cf5851050 35 fields · synced Jul 17, 2026
- EUDAMED 5486f66c-4f79-4604-aa73-798c2ca0bffa 61 fields · synced Jul 17, 2026