45648ebt
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Thompson FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Radio Concave Tapered w/Teeth 23x60mm FDA UDI
- Model / Reference
- Thompson Retractor System EUDAMED45648EBT EUDAMEDFDA UDI
- Description
- Radio Concave Tapered w/Teeth 23x60mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841536128833 EUDAMEDFDA UDI
- Basic UDI-DI
- 008415361TRMR EUDAMED
- Direct Marketing DI
- 00841536128833 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 IIa 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
The 45648EBT device, a Thompson Retractor System, is a medical device used in surgical procedures. It features a sterile design and follows standard industry regulations. For detailed information on this product, consult the manufacturer's website or contact their support team.
Similar devices
Also classified as Surgical retraction system, reusable.
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- GRACEY 14 TALON TOUGH QUIK TIP — American Eagle Instruments · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 008415361TRMR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Thompson Surgical Instruments, Inc.
- EUDAMED SRN
- US-MF-000013232
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 83748ab6-7b1c-4cd3-a062-d0da07e6e7dd 61 fields · synced Jul 18, 2026
- FDA UDI 6fed4478-9865-44e0-ad2c-35fd1b7ae20b 34 fields · synced May 30, 2026