Acs COMO02E

by American Contract Systems, Inc.

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

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	Number00191072045621 UDI-DI	Date27 Sep 2018Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Acs
Generic Name: General surgical procedure kit, non-medicated, single-use
Model / Reference: COMO02E

Primary DI / UDI-DI: 00191072045621
FDA Product Code: LRO
GMDN Term: General surgical procedure kit, non-medicated, single-use

Device Class: Class II
Regulation Number: 878.4370
GUDID distribution status: In Commercial Distribution

Sterilization Method: Ethylene Oxide

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Properties

Sterile
Single Use
Convenience Kit
Premarket Exempt
Lot / Batch Number
Serial Number

Other properties (8)

Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Combination Product: No
HCT/P: No
Expiration Date: No
Manufacturing Date: No