Identity
- Trade Name
- Rod Cutter FDA UDI
- Generic Name
- Wire cutter FDA UDI
- Device Name
- Implant Rod Sheer, Cuts 4.8, 5.5 and 6.3mm Rods, 51cm Length FDA UDI
- Model / Reference
- 7781-30 FDA UDI
- Description
- Implant Rod Sheer, Cuts 4.8, 5.5 and 6.3mm Rods, 51cm Length FDA UDI
Identifiers
- Catalog Number
- 7781-30 FDA UDI
- Primary DI / UDI-DI
- 10840199532923 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Wire cutter
Rod Cutter by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wire cutter.
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- Sklar — Sklar Corporation · Class I
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class I
- Reicodent — devemed GmbH · Class I
- gSource — GSOURCE, LLC. · Class I
- FRAGMENT FIXATION SYSTEM — Orthofix, Inc. · Class II
- gSource — GSOURCE, LLC. · Class I
- ZOLL-DENTAL — Zoll-Dental · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Koros USA, Inc.
Sources (1)
- FDA UDI 6841fa1c-b1c3-4b7f-8018-fcee552892a8 37 fields · synced May 30, 2026