Identity
- Trade Name
- gSource FDA UDI
- Generic Name
- Wire cutter FDA UDI
- Device Name
- Wire Cutter DA 6 1/2", angled, TC, max cap 1.6mm [.062"] FDA UDI
- Model / Reference
- gS 83.7228 FDA UDI
- Description
- Wire Cutter DA 6 1/2", angled, TC, max cap 1.6mm [.062"] FDA UDI
Identifiers
- Catalog Number
- gS 83.7228 FDA UDI
- Primary DI / UDI-DI
- M7558372280 FDA UDI
- FDA Product Code
- HXZ FDA UDI
- GMDN Term
- Wire cutter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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
Yes
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: Wire cutter
A heavy-duty, hand-held manual surgical instrument used for cutting orthopaedic wires, cerclages, and small diameter pins or bolts in orthopedic procedures.
Similar devices
Also classified as Wire cutter.
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- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class I
- Reicodent — devemed GmbH · Class I
- FRAGMENT FIXATION SYSTEM — Orthofix, Inc. · Class II
- ZOLL-DENTAL — Zoll-Dental · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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 c8269690-c344-40bd-8f2a-f61afb6eb2df 34 fields · synced Jun 26, 2026