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Sklar® 21-386

by Sklar Corporation

Sklar 21-386 is an uterine sound (FDA Class I; FDA product code GEN, Forceps, General & Plastic Surgery) made by Sklar Corporation, listed in FDA GUDID since 19 Jul 2018 (UDI-DI 40649111047719), 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 Number40649111047719 UDI-DI Date19 Jul 2018ListedStatusListed 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  • Withdrawn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
Uterine sound, single-use
Model / reference
21-386
Primary DI / UDI-DI
40649111047719
FDA product code
GEN
GMDN term
Uterine sound, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Uterine sound, single-use

Similar devices

Other devices filed under FDA product code GEN (FORCEPS, GENERAL & PLASTIC SURGERY).

Other devices from Sklar Corporation

See all devices from Sklar Corporation →

Properties

  • Sterilise before use
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (10, all answered No)