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Henry Schein 9007447

by Henry Schein, Inc. 2 variants

Henry Schein 9007447 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K931202 on 16 Dec 1993 and listed in FDA GUDID since 30 Nov 2017 (UDI-DI 10304040060930), 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) K931202

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 Number10304040060930 UDI-DI Date30 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK931202 Date16 Dec 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K931202 decided 16 Dec 1993 Active
  • FDA GUDID UDI-DI 10304040060930 listed 30 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K931202
  2. Listed FDA GUDID 10304040060930

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  • Withdrawn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
Sterilization packaging, single-use
Model / Ref / Catalog
9007447
Primary DI / UDI-DI
10304040060930
510(k) Number
FDA product code
FRG
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sterilization packaging, single-use

Cleared under the same submission (K931202)

and 8 more cleared under K931202

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

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