Identity
- Trade Name
- Tx™ FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Device Name
- DISC SHAVER, 6mm, WINDOW, SST FDA UDI
- Model / Reference
- LS-398-6 FDA UDI
- Description
- DISC SHAVER, 6mm, WINDOW, SST FDA UDI
Identifiers
- Primary DI / UDI-DI
- M711LS39860 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic chisel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
No
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: Orthopaedic chisel
Tx™ by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic chisel.
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Gimmi — Gimmi GmbH · Class I
- CHISEL — KLS-Martin L.P. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- gSource — GSOURCE, LLC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Novo Surgical — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Innovasis, Inc.
Sources (1)
- FDA UDI d4a911e1-3a30-4da9-9450-0e8df9305aee 34 fields · synced May 30, 2026