What is FDA product code PKD?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

General & Plastic Surgery › SurgicalLaceration Tray

Centurion

Name: Centurion
Brand: Centurion

4 catalogue numbers from SUT18765A, listed by Centurion Medical Products Corporation, United States, under Laceration Tray. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

4catalogue 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 Centurion
Listed by	Centurion Medical Products Corporation, United States
FDA product code	PKD
Device type	Laceration Tray
Device class	Class 1
Regulation	21 CFR 878.4014
Premarket notification	Exempt
Record published	2022-01-02
Record revised	2026-07-29 (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
Packaging	Case of 16, case of 20

Catalogue Numbers

Catalogue numbers for Centurion
Catalogue number	Size	Status
SUT18765A		In distribution
SUT15260		In distribution
SUT17155		In distribution
SUT19145		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
Cardinal Health	Cardinal Health 200, LLC	64
Trinity Sterile, Inc.	Trinity Sterile, Inc.	8
Stradis Healthcare	Stradis Healthcare	7
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.