Identity
- Trade Name
- GFS BTB Link EUDAMEDGFS BTB FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- GFS BTB Link FDA UDI
- Model / Reference
- 11160 EUDAMEDFDA UDIGFS BTB EUDAMED
- Description
- GFS BTB Link FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816342024976 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816342024976 EUDAMED
- FDA Product Code
- MBI FDA UDI
- EMDN Code
- H900301 SUTURE BUTTONS EUDAMED
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Gfs Btb by Parcus Medical Llc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
- Hi-Fi — Conmed Corporation · Class II
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- GII PANACRYL — DePuy Mitek, Inc. · Class II
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- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Parcus Medical Llc
Sources (2)
- FDA UDI 17ea87e0-3447-4c9e-ab55-4c62c5802f04 33 fields · synced Jul 9, 2026
- EUDAMED 68a4cbdb-0552-45a6-8470-5e29b538e22e 61 fields · synced Jul 9, 2026