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Thompson
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10050000LABModel Thompson Retractor System
Identity
- Trade Name
- Instrument Case L/A Base EUDAMEDThompson FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Case L/A Base FDA UDI
- Model / Reference
- 10050000LAB EUDAMEDFDA UDIThompson Retractor System EUDAMED
- Description
- Instrument Case L/A Base FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851099006486 EUDAMEDFDA UDI
- Basic UDI-DI
- 008415361TRMR EUDAMED
- Direct Marketing DI
- 00851099006486 EUDAMED
- 510(k) Number
- K151347 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
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: Instrument tray, reusable
Thompson by Thompson Surgical Instruments — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
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Cleared under the same submission
K151347 also covers:
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
- Thompson — Thompson Surgical Instruments
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thompson Surgical Instruments
Sources (2)
- FDA UDI e9397a50-f640-4ce4-b719-34173aeb3446 34 fields · synced Jun 20, 2026
- EUDAMED f1a9f23e-953c-454b-9508-e1bf61bf6cb9 61 fields · synced Jun 20, 2026