Identity
- Trade Name
- Geminus FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Model / Reference
- GEMINUS Volar Distal Radius Plate System Accessory Module 1 FDA UDI
Identifiers
- Catalog Number
- GMN-ACC-MOD1 FDA UDI
- Primary DI / UDI-DI
- 00841506100456 FDA UDI
- 510(k) Number
- K102103 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Device sterilization/disinfection container, reusable
Geminus by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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Cleared under the same submission
K102103 also covers:
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Align — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI 7dd04554-1a0c-4de9-b091-7465d77b5ac9 35 fields · synced Jun 6, 2026