← Back to catalogue

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
ROBOT GYN PACK FDA UDI
Model / Reference
ESRG94B FDA UDI
Description
ROBOT GYN PACK FDA UDI

Identifiers

Primary DI / UDI-DI
00191072218261 FDA UDI
FDA Product Code
OHD FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1720 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

The ACS device is a comprehensive surgical procedure kit designed for general gynecological laparoscopic surgeries. It features multiple non-dedicated instruments, including surgical scissors, forceps, and retractors, which are not intended to be used during anesthesia or patient preparation. This single-use device is suitable for use in an open abdominal surgery setting and is not a dedicated biopsy kit.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
American Contract Systems, Inc.

Sources (1)

  • FDA UDI 3d281d34-b2af-4de3-9d94-3c9ae51c8960 33 fields · synced Jul 29, 2026