Comply™ SteriGage™ 1243B

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number30707387469086 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK771080	Date14 Jul 1977Decided	StatusActive

Official records

AccessGUDID record UDI-DI 30707387469086
FDA 510(k) database 510(k) number K771080

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Comply™ SteriGage™
Generic name: Chemical/physical sterilization process indicator
Model / Ref / Catalog: 1243B

Primary DI / UDI-DI: 30707387469086
FDA product code: JOJ
GMDN term: Chemical/physical sterilization process indicator

Device class: Class II
Regulation number: 880.2800
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Lot / batch number
Expiration date

Other properties (12)

Supplied sterile: No
Sterilise before use: No
Implantable: No
Contains latex: No
Prescription use: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No