Who else makes this device?

Name: Cook
Brand: Cook

Cook · Instruments, Surgical, Cardiovascular → Cardiovascular

6manufacturers in China registered for this device type

1catalogue number

1recall

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code DWS
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Xinhua Surgical Instrument Co., Ltd.	Zibo	Shandong	Manufacturer	222
Asol Co., Ltd.	Huaian	Jiangsu	Manufacturer	22
Huaian Tisurg Medical Instruments Co., Ltd.	Huaian	Jiangsu	Contract manufacturer	22
Huaian Wolfram Surgical Instruments	Huaian	Jiangsu	Manufacturer	14
Global Medical Production Co., Ltd.	Jiaxing	Zhejiang	Manufacturer	10

Record

Regulatory record for Cook
Listed by	Cook Vandergrift Inc., United States
FDA product code	DWS
Device type	Instruments, Surgical, Cardiovascular
Device class	Class 1
Regulation	21 CFR 870.4500
Establishment	Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2023-11-16

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Store in dark, dry, cool place.
Packaging	Box

Catalogue Numbers

Catalogue numbers for Cook
Catalogue number	Size	Status
G58341		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Delacroix-Chevalier	Landanger	1,819
Landanger	Landanger	1,213
Ambler Surgical	Ambler Surgical, LLC	1,013
Pilling	Teleflex Medical LLC	971
Wexler Surgical, Inc.	Wexler Surgical, Inc.	876
V. Mueller	Steris Corporation	716
Novo Surgical	Novo Surgical, Inc.	387
Integra® Jarit®	Integra LifeSciences Production Corporation	364
Instruments, Surgical, Cardiovascular	Fehling Instruments GmbH	352
Novo Surgical Inc.	Novo Surgical, Inc.	290
Avalign	Avalign Technologies, Inc.	283
Millennium	Avalign Technologies, Inc.	272

Showing 12 of 472. All products under Instruments, Surgical, Cardiovascular

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
2023-07-24	Class II	Under Investigation by firm	Sterility of device may be compromised due to breach of the chevron seal of the packaging	15,951

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.

Cook