Identity
- Trade Name
- TOPS Instrumentation Container FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Model / Reference
- 83117 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115932799 FDA UDI
- PMA Number
- P220002 FDA UDI
- FDA Product Code
- QWK FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class III 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
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
Category: Device sterilization/disinfection container, reusable
TOPS Instrumentation Container by Premia Spine Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P220002 also covers:
- Alignment Gauge handle Long — PREMIA SPINE LTD
- Alignment Gauge handle Medium — PREMIA SPINE LTD
- Ball Probe — PREMIA SPINE LTD
- Ball Sleeve Assy — PREMIA SPINE LTD
- Cannulated Pedicle Awl — PREMIA SPINE LTD
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 5.5 mm — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Cannulated Tap Ø5.5 XL — PREMIA SPINE LTD
- Cannulated Tap Ø6.5 XL — PREMIA SPINE LTD
- Counter Torque — PREMIA SPINE LTD
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Premia Spine Ltd
Sources (1)
- FDA UDI cea2c6a4-bdd0-48fc-b986-830057eac79a 33 fields · synced May 30, 2026