Identity
- Trade Name
- K WIRE TROCAR PIN FDA UDI
- Generic Name
- Clavicle intramedullary nail-like rod FDA UDI
- Device Name
- K WIRE TROCAR PIN ROUND FDA UDI
- Model / Reference
- 1106-714 FDA UDI
- Description
- K WIRE TROCAR PIN ROUND FDA UDI
Identifiers
- Primary DI / UDI-DI
- B09911067140 FDA UDI
- 510(k) Number
- K100736 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Clavicle intramedullary nail-like rod FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Dimensions & Sizes
- Size
- Width — 1.3 Millimeter FDA UDILength — 500 Millimeter FDA UDI
K Wire Trocar Pin by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K100736 also covers:
- Batrik K-Wire & Steinman Pins — Batrik Medical Manufacturing Inc
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 51110bd9-209e-4039-ac9f-2b9f36d2f1cf 37 fields · synced Jun 8, 2026