Identity
- Trade Name
- Streamline TL Spinal Fixation System FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- SCREW CADDY FDA UDI
- Model / Reference
- 02-65-L-SCREW-CDY FDA UDI
- Description
- SCREW CADDY FDA UDI
Identifiers
- Catalog Number
- 02-65-L-SCREW-CDY FDA UDI
- Primary DI / UDI-DI
- 00191083005744 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Streamline TL Spinal Fixation System by Pioneer Surgical Technology, 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
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI b6aad290-5523-4961-a1e0-5935b0fe9676 36 fields · synced May 31, 2026