GFS II Standard, Large and Mini
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- GFS II LG 35 EUDAMEDGFS II Standard, Large and Mini FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- GFS II LG 35 FDA UDI
- Model / Reference
- 10707 EUDAMEDFDA UDIGFS II Large EUDAMED
- Description
- GFS II LG 35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816342021746 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816342021746 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Tendon/ligament bone anchor, non-bioabsorbable
GFS II Standard, Large and Mini 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.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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 fb6a11e7-5287-4846-8170-51f367eb3482 33 fields · synced Jun 19, 2026
- EUDAMED 3981a2a1-20e2-4d62-a347-d8014e0eb726 61 fields · synced Jun 19, 2026