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Surgistar 8191

by Surgistar Inc.

Surgistar 8191 is a Class I device made by Surgistar Inc., listed in FDA GUDID since 2 Aug 2016 (UDI-DI 00878799002860), 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 Number00878799002860 UDI-DI Date2 Aug 2016ListedStatusListed 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  • Withdrawn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
Surgistar
Generic name
Cotton pledget applicator, single-use
Model / reference
8191
Primary DI / UDI-DI
00878799002860
FDA product code
KCJ
GMDN term
Cotton pledget applicator, single-use
Device class
Class I
Regulation number
874.5220
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cotton pledget applicator, single-use

Other devices from Surgistar Inc.

  • Surgistar 8119

    Class I

  • Surgistar 196469

    Class I

  • Surgistar 8120

    Class I

  • Surgistar 184921

    Class I

See all devices from Surgistar Inc. →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)