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McCulloch Retractor Frame, Jointed Arms 70 mm

by Surtex Instruments Ltd EUDAMEDGUDID

Active European Union

Ref RT-990-43

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05056111302361 UDI-DIDate12 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number50554459RETRACTIONG3 Basic UDI-DIDate16 Mar 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
McCulloch Retractor Frame, Jointed Arms 70 mm EUDAMED
Surtex GUDID
Generic Name
Self-retaining surgical retractor, reusable
Device Name
Hook & Retractors
Model / Reference
RT-990-43
Primary DI / UDI-DI
05056111302361
Basic UDI-DI
50554459RETRACTIONG3
FDA Product Code
GAD
EMDN Code
L03140101 Self-static spreaders, reusable
GMDN Term
Self-retaining surgical retractor, reusable
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Spain
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Manufacturer details

EUDAMED SRN
GB-MF-000023183
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Surtex Instruments Ltd

See all devices from Surtex Instruments Ltd →

Properties

  • Reusable
  • Premarket Exempt

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No