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Sklar 97-589

by Sklar Corporation

Sklar 97-589 is a Class I device made by Sklar Corporation, listed in FDA GUDID since 13 Mar 2019 (UDI-DI 10649111191404), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10649111191404 UDI-DI Date13 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sklar
Generic name
Airway tube forceps, reusable
Model / reference
97-589
Primary DI / UDI-DI
10649111191404
FDA product code
GEN
GMDN term
Airway tube forceps, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Airway tube forceps, reusable

Other devices from Sklar Corporation

See all devices from Sklar Corporation →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (11, all answered No)