Thompson

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref SL44380Model Thompson Retractor System

by Thompson Surgical Instruments

Identity

Trade Name: Radio Fine Vessel 200mm EUDAMED
Thompson FDA UDI
Generic Name: Surgical retraction system, reusable FDA UDI
Device Name: Radio Fine Vessel 200mm FDA UDI
Model / Reference: SL44380 EUDAMEDFDA UDI
Thompson Retractor System EUDAMED
Description: Radio Fine Vessel 200mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00841536127942 EUDAMEDFDA UDI
Basic UDI-DI: 008415361TRMR EUDAMED
Direct Marketing DI: 00841536127942 EUDAMED
510(k) Number: K151347 FDA UDI
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 EUDAMED
Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical retraction system, reusable

Thompson by Thompson Surgical Instruments — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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

Cleared under the same submission

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 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 e8d3438c-eebc-42fc-979a-3a8c231ce148 34 fields · synced Aug 1, 2026
EUDAMED 56644f0a-68e5-42e1-8c85-67b8e0b1ef1c 61 fields · synced Aug 1, 2026