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Henry Schein 1025397

by Henry Schein, Inc.

Henry Schein 1025397 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K050887 on 11 Jul 2005 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040001295), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K050887

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00304040001295 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK050887 Date11 Jul 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050887 decided 11 Jul 2005 Active
  • FDA GUDID UDI-DI 00304040001295 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050887
  2. Listed FDA GUDID 00304040001295

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Henry Schein
Generic name
Vaginal speculum, single-use
Model / Ref / Catalog
1025397
Description
Vaginal Speculum Dispos Medium
Primary DI / UDI-DI
00304040001295
510(k) Number
FDA product code
HIB
GMDN term
Vaginal speculum, single-use
Device class
Class II
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vaginal speculum, single-use

Cleared under the same submission (K050887)

and 8 more cleared under K050887

Similar devices

Other devices filed under FDA product code HIB (Speculum, vaginal, nonmetal).

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)