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Acs

FDA UDI

Class I (US FDA UDI)

by American Contract Systems, Inc.

Identity

Trade Name
ACS FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
SDS HAND DRAPING PACK FDA UDI
Model / Reference
SJHD25A FDA UDI
Description
SDS HAND DRAPING PACK FDA UDI

Identifiers

Primary DI / UDI-DI
00191072224378 FDA UDI
FDA Product Code
OJH FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

Acs by American Contract Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Contract Systems, Inc.

Sources (1)

  • FDA UDI 402a4301-2a9d-4588-8898-000347e0f7c6 33 fields · synced Jun 1, 2026