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Acs

FDA UDI

Class II (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
OFF PUMP CABG PACK - 170316 FDA UDI
Model / Reference
BHOP48F FDA UDI
Description
OFF PUMP CABG PACK - 170316 FDA UDI

Identifiers

Primary DI / UDI-DI
00191072015747 FDA UDI
FDA Product Code
LRO FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

Yes

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

The ACS General Surgery Tray is a comprehensive, single-use surgical instrument kit designed for general surgery procedures, including open abdominal surgery, minor dermatological surgery, and cosmetic surgery. This kit includes various instruments such as retractors, forceps, and scalpels, making it ideal for surgeons who prefer not to use dedicated scrubbing or patient preparation devices.

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 f91cef6a-8690-49e6-b597-b159e760a775 33 fields · synced Aug 4, 2026