ACS

Sterile Cardiovascular Supply Labels

Registry build 21.09.26
4manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Anhui (2), Jiangsu (1), Guangdong (1).

Chinese manufacturers registered for FDA product code LYV
Manufacturer City Province Registered as Device types
TF NEW Material SCI AND TEC Co., Ltd. Huainan Anhui Manufacturer 51
Hefei Mlush Sanitary Products Co., Ltd. Hefei Anhui Manufacturer 48
Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 17
Dongguan Linghui Optoelectronic Technology Co., Ltd. Dongguan Guangdong Manufacturer 2

Record

Regulatory record for ACS
Listed by American Contract Systems, Inc.
FDA product code LYV
Device type Label Or Tag, Sterile
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2020-05-11
Record revised 2022-06-17 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for ACS
Catalogue number Size Status
UISL00A In distribution
ALLB90A In distribution
ANST05C In distribution
ALAL45C In distribution
UISL02B In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Centurion Centurion Medical Products Corporation 979
Medline Industries, Inc. Medline Industries, Inc. 261
PharmaTags Rmac Surgical Inc 105
Medimark Sheet Tape Sontec Instruments, Inc. 74
E-Z ID Rings Zirc Dental Products, Inc. 59
E-Z ID Tape Zirc Dental Products, Inc. 32
Key Surgical Sterile Labels Key Surgical, LLC 25
PAL™ Merit Medical Systems, Inc. 21
Cygnus Aspen Surgical Products, Inc. 20
Sterile Labels Key Surgical, LLC 12
Label Or Tag, Sterile Key Surgical, LLC 12
Richard-Allan® Utility Marker with Labels Aspen Surgical Products, Inc. 11

Showing 12 of 2,086. All products under Label Or Tag, Sterile

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer