Identity
- Trade Name
- General Instruments FDA UDI
- Generic Name
- Orthopaedic implantable-device cutter FDA UDI
- Device Name
- High Performance Rod Cutter FDA UDI
- Model / Reference
- CI-10359-01 FDA UDI
- Description
- High Performance Rod Cutter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811801037306 FDA UDI
- FDA Product Code
- HTZ FDA UDI
- GMDN Term
- Orthopaedic implantable-device cutter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implantable-device cutter
General Instruments by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implantable-device cutter.
- Tecomet — Tecomet,Inc · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Tecomet — Tecomet,Inc · Class I
- BOLT/NUT SET — SONTEC INSTRUMENTS, INC. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- PLUG CUTTER — SONTEC INSTRUMENTS, INC. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Specials — SeaSpine Orthopedics Corporation · 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
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI 4252e080-c2da-40a0-9483-e4c73be1120a 34 fields · synced Jun 8, 2026