Cardinal Health

Laceration Tray TMC ITEM#13111

Registry build 21.09.26
1manufacturer
64catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PKD
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127

Record

Regulatory record for Cardinal Health
Listed by Cardinal Health 200, LLC, United States
FDA product code PKD
Device type Laceration Tray
Device class Class 1
Regulation 21 CFR 878.4014
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-09-27
Record revised 2022-06-17 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 15 to 30 °C
Packaging Case of 20, case of 10, case of 12, case of 16, case of 28, case of 22

Catalogue Numbers

Catalogue numbers for Cardinal Health
Catalogue number Size Status
16-0856A In distribution
08A7523B In distribution
08-1410E In distribution
16A6755A In distribution
08-8880C In distribution
08-1422A In distribution
08-2537B In distribution
08-9720A In distribution
08-7921D In distribution
SER42LWT27 In distribution
08-7921J In distribution
08-8880B In distribution
SER42LWT30 In distribution
05-2295A In distribution
08A7523A In distribution
08-7921P In distribution
SER42LWT26 In distribution
08-7921N In distribution
SBA69LDMVA In distribution
08-8880A In distribution
16-5807A In distribution
08-0963D In distribution
08-4330A In distribution
08-2537D In distribution
NI05-0174A In distribution
08-7921L In distribution
08-2295G In distribution
08-7921T In distribution
08-7921B In distribution
05-5000A In distribution
SER42LWT25 In distribution
08-7921I In distribution
08-1410F In distribution
08-7921C In distribution
08-1410C In distribution
08-2295C In distribution
08-1410D In distribution
SER40LRHMA In distribution
08-5807A In distribution
05-4856F In distribution
08-1410A In distribution
08-2537A In distribution
08-7921O In distribution
SER33MLAHB In distribution
08-2295A In distribution
08-7921Q In distribution
08-1410B In distribution
08-4856A In distribution
08-7921F In distribution
08-7921H In distribution
08-0153A In distribution
08A7523C In distribution
16-2503A In distribution
08-2026A In distribution
08-7921G In distribution
SER42LWT31 In distribution
16-6755A In distribution
16-2503B In distribution
05-9397A In distribution
SER42LWT29 In distribution
SER42LWT28 In distribution
08-7921V In distribution
08-6755A In distribution
08-2295D In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Industries, Inc. Medline Industries, Inc. 164
Centurion Medical Products Corp Medline Industries, Inc. 67
Trinity Sterile, Inc. Trinity Sterile, Inc. 8
Stradis Healthcare Stradis Healthcare 7
Centurion Centurion Medical Products Corporation 4
Invenio GRI Medical & Electronic Technology Co., Ltd. 1
MediChoice Owens & Minor Distribution, Inc. 1

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