Thompson
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Radio Conc Sh 25x110mm Sq Lip EUDAMEDThompson FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Radio Conc Sh 25x110mm Sq Lip FDA UDI
- Model / Reference
- SL6845 EUDAMEDFDA UDIThompson Retractor System EUDAMED
- Description
- Radio Conc Sh 25x110mm Sq Lip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841536133813 EUDAMEDFDA UDI
- Basic UDI-DI
- 008415361THM5 EUDAMED
- Direct Marketing DI
- 00841536133813 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical retraction system, reusable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical retraction system, reusable
Thompson Surgical Instruments' Thompson Retractor is a versatile, reusable device designed for general plastic surgery procedures. This instrument features a frame-like assembly of surgical instruments intended to create a self-locking mechanism to temporarily part tissue.
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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thompson Surgical Instruments
Sources (2)
- FDA UDI 9ee2759b-937d-42e8-9197-864e4d19716e 34 fields · synced Jul 10, 2026
- EUDAMED cd32a9a4-674e-4636-b5d2-45ef19bca32c 61 fields · synced Jul 10, 2026