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Carlson-Haynes Universal Retractor 991-MC1

by Grace Medical, Inc.

Ref 991-MC1Model ENT Manual Reusable Surgical Instruments

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08445050024LJ Basic UDI-DI 00844505010917UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844505010917 UDI-DI Date21 Sep 2018ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Carlson-Haynes Universal Otologic Retractor EUDAMED
Carlson-Haynes Universal Retractor GUDID
Generic Name
Self-retaining surgical retractor, reusable
Model / Reference
991-MC1, ENT Manual Reusable Surgical Instruments
Primary DI / UDI-DI
00844505010917
Basic UDI-DI
08445050024LJ
Direct Marketing DI
00844505010917
FDA Product Code
KAL
EMDN Code
L149003 ENT retractors, reusable
GMDN Term
Self-retaining surgical retractor, reusable
Device Class
Class I
Regulation Number
874.4420
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Self-retaining surgical retractor, reusable

Other devices from Grace Medical, Inc.

See all devices from Grace Medical, Inc. →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No