Identity
- Trade Name
- Link Embrace Shoulder System - Instruments FDA UDI
- Generic Name
- Glenoid orthopaedic reamer FDA UDI
- Device Name
- Glenoid orthopaedic reamer - LINK Embrace Shoulder System FDA UDI
- Model / Reference
- 645-001/36 FDA UDI
- Description
- Glenoid orthopaedic reamer - LINK Embrace Shoulder System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04026575279715 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Glenoid orthopaedic reamer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Glenoid orthopaedic reamer
Link Embrace Shoulder System - Instruments by WALDEMAR LINK GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glenoid orthopaedic reamer.
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- Alliance — Zimmer, Inc. · Class II
- PRIMA TT Glenoid — Limacorporate · Class II
- OFF AXIS COMP MINI REAMER 6-SPOKE LG — Biomet Orthopedics, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI 377c46c0-2131-4603-a4c8-91670b28d81d 33 fields · synced Jun 6, 2026