Identity
- Trade Name
- DTRAX® Spinal System-L FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, single-use FDA UDI
- Device Name
- A set of individual non-powered, disposable, hand-held surgical instruments intended and indicated for preparation of a spinal joint to aid in fusion. The set contains trial spacers, an awl, and a screwdriver. FDA UDI
- Model / Reference
- DX-22-600 FDA UDI
- Description
- A set of individual non-powered, disposable, hand-held surgical instruments intended and indicated for preparation of a spinal joint to aid in fusion. The set contains trial spacers, an awl, and a screwdriver. FDA UDI
Identifiers
- Catalog Number
- DX-22-600 FDA UDI
- Primary DI / UDI-DI
- 00852776006188 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Internal spinal fixation procedure kit, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Internal spinal fixation procedure kit, single-use
DTRAX® Spinal System-L by Providence Medical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Providence Medical Technology, Inc.
Sources (1)
- FDA UDI f78fb550-ed1f-4522-a5d7-ff1ee90af710 34 fields · synced May 30, 2026