Identity
- Trade Name
- Thompson FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Concave Tapered 20x75mm FDA UDI
- Model / Reference
- 6363 FDA UDI
- Description
- Concave Tapered 20x75mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841536138856 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Surgical retraction system, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical retraction system, reusable
Thompson by Thompson Surgical Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- GRACEY 14 TALON TOUGH QUIK TIP — American Eagle Instruments · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Straight stem trial , PSA , Ø10 × 100mm — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class I
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
- Thompson Surgical Instruments
Sources (1)
- FDA UDI eebf5bb1-31d8-4872-8b11-0367ee3f5568 34 fields · synced May 31, 2026