Identity
- Trade Name
- Distractor Shaver, 5x9mm FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Model / Reference
- 6192-03 FDA UDI
Identifiers
- Catalog Number
- 6192-03 FDA UDI
- Primary DI / UDI-DI
- 81195401223624 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not 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
Distractor Shaver, 5x9mm by Interventional Spine, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Interventional Spine, Inc
Sources (1)
- FDA UDI 137a1af8-6782-4e7b-82e8-f93f75c1c106 35 fields · synced May 31, 2026