Identity
- Trade Name
- gSource FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- K-Wire D. Trocar 5" 0.7mm [.028"] pkg/6 FDA UDI
- Model / Reference
- 78.2050 FDA UDI
- Description
- K-Wire D. Trocar 5" 0.7mm [.028"] pkg/6 FDA UDI
Identifiers
- Catalog Number
- gS 78.2050 FDA UDI
- Primary DI / UDI-DI
- M7557820501 FDA UDI
- 510(k) Number
- K100736 FDA UDI
- FDA Product Code
- KDW FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Orthopaedic bone wire
gSource by Gsource, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone wire.
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- APTUS — Medartis Inc. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Gsource, Llc.
Sources (1)
- FDA UDI 722c058b-56f6-4019-8aca-7e29ceefef2a 35 fields · synced May 30, 2026