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Restore
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 232015Model General Orthopedic Use Tendon and Graft Sizer
Identity
- Trade Name
- RESTORE GRAFT SIZER EUDAMEDRESTORE FDA UDI
- Generic Name
- Ligament graft sizer, noninvasive FDA UDI
- Device Name
- Tendon and Graft Sizer EUDAMEDRESTORE GRAFT SIZER 8-12mm (Plus or Minus 2 Percent) FDA UDI
- Model / Reference
- 232015 EUDAMEDFDA UDIGeneral Orthopedic Use Tendon and Graft Sizer EUDAMED
- Description
- RESTORE GRAFT SIZER 8-12mm (Plus or Minus 2 Percent) FDA UDI
Identifiers
- Catalog Number
- 232015 FDA UDI
- Primary DI / UDI-DI
- 10886705010950 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00158KT EUDAMED
- Direct Marketing DI
- 10886705010950 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Ligament graft sizer, noninvasive 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
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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: Ligament graft sizer, noninvasive
Restore by Medos International Sàrl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ligament graft sizer, noninvasive.
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- Arthrex® — Arthrex, Inc. · Class I
- CONMED — Conmed Corporation · Class I
- LINK Instruments - Trial implants and size gauges — WALDEMAR LINK GmbH & Co. KG · Class I
- LINK Instruments - Trial implants and size gauges — WALDEMAR LINK GmbH & Co. KG · Class I
- CONMED — Conmed Corporation · 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 e70a9258-25cc-45c8-b685-5d105370b134 35 fields · synced Aug 3, 2026
- EUDAMED ac0bf756-9a1c-4477-86b7-a7df342611a1 61 fields · synced Aug 3, 2026