Henry Schein 1013343

by Henry Schein, Inc.

Henry Schein 1013343 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K870147 on 23 Apr 1987 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040006085), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00304040006085 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK870147	Date23 Apr 1987Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00304040006085
FDA 510(k) database 510(k) number K870147

Across registries

2 registries list this device

FDA 510(k) K870147 decided 23 Apr 1987 Active
FDA GUDID UDI-DI 00304040006085 listed 24 Sep 2016 Listed

Timeline

2 dated events

23 Apr 1987 Cleared FDA 510(k) K870147
24 Sep 2016 Listed FDA GUDID 00304040006085

Coverage

1 jurisdiction

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Withdrawn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: 1013343

Primary DI / UDI-DI: 00304040006085
510(k) Number: K870147
FDA product code: FRG
GMDN term: Sterilization packaging, single-use

Device class: Class II
Regulation number: 880.6850
GUDID distribution status: In Commercial Distribution

Size: Width — 4 Inch

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Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)