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.

Stradis Healthcare · Laceration Tray → General & Plastic Surgery

Name: Stradis Healthcare
Brand: Stradis Healthcare

1manufacturer

7catalogue numbers in this listing

1recall

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 Stradis Healthcare
Listed by	Stradis Healthcare, United States
FDA product code	PKD
Device type	Laceration Tray
Device class	Class 1
Regulation	21 CFR 878.4014
Premarket notification	Exempt
Record published	2022-04-26
Record revised	2023-01-27 (version 5)

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 20, case of 14
Distribution end date	2023-01-31

Catalogue Numbers

Catalogue numbers for Stradis Healthcare
Catalogue number	Size	Status
ZZ-0683		In distribution
619-021		Withdrawn
570-2728		Withdrawn
570-2396		Withdrawn
ZZ-0684		Withdrawn
619-025		Withdrawn
619-020		Withdrawn

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
Centurion	Centurion Medical Products Corporation	4
Invenio	GRI Medical & Electronic Technology Co., Ltd.	1
MediChoice	Owens & Minor Distribution, Inc.	1

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2022-12-15	Class II	Process control	Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.	300 units

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.

Stradis Healthcare