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Sklar® 21-313

by Sklar Corporation

Sklar® 21-313 is a Class I device made by Sklar Corporation, listed in FDA GUDID since 13 Aug 2018 (UDI-DI 40649111037680), 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 Number40649111037680 UDI-DI Date13 Aug 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  • Withdrawn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
Vaginal speculum, single-use
Model / reference
21-313
Primary DI / UDI-DI
40649111037680
FDA product code
HDF
GMDN term
Vaginal speculum, single-use
Device class
Class I
Regulation number
884.4520
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Vaginal speculum, single-use

Similar devices

Other devices filed under FDA product code HDF (SPECULUM, VAGINAL, METAL).

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)