Identity
- Trade Name
- Streamline Navigated Instruments FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- TL SCREW INSERTER, MODULAR FDA UDI
- Model / Reference
- 02-SCREWINS-CL-MDN FDA UDI
- Description
- TL SCREW INSERTER, MODULAR FDA UDI
Identifiers
- Catalog Number
- 02-SCREWINS-CL-MDN FDA UDI
- Primary DI / UDI-DI
- 00846468095819 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
No
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 Navigated Instruments by Pioneer Surgical Technology, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI cac09537-1f5b-4b74-93bb-a6908827c3a7 36 fields · synced Jun 8, 2026