Identity
- Trade Name
- Threaded Hand Nail FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Model / Reference
- Threaded Hand Nail System Sterilization Tray, Insert FDA UDI
Identifiers
- Catalog Number
- THN-INSRT FDA UDI
- Primary DI / UDI-DI
- 00841506135182 FDA UDI
- 510(k) Number
- K230908 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Threaded Hand Nail 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
K230908 also covers:
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — SKELETAL DYNAMICS L.L.C.
- Threaded Hand Nail — 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 |
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Manufacturer
- Manufacturer
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI 7be85c55-1677-4cb9-b9b0-ddd1d7c727cb 35 fields · synced May 30, 2026