Who else makes this device?

Name: Cook-Z
Brand: Cook-Z

Cook-Z · Prosthesis, Tracheal, Expandable → General & Plastic Surgery

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JCT
Manufacturer	City	Province	Registered as	Device types
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49

Record

Regulatory record for Cook-Z
Listed by	Cook Incorporated, United States
FDA product code	JCT
Device type	Prosthesis, Tracheal, Expandable
Device class	Class 2
Regulation	21 CFR 878.3720
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2015-10-24
Record revised	2018-03-29 (version 2)

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.

Catalogue Numbers

Catalogue numbers for Cook-Z
Catalogue number	Size	Status
G08682		In distribution
G08683		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Hanarostent® Trachea/Bronchium(CCC)	M.I.Tech Co Ltd	84
Bonastent® Tracheal/Bronchial	Sewoon Medical Co., Ltd.	83
Aero®	Merit Medical Systems, Inc.	37
Ultraflex™ Tracheobronchial	Boston Scientific Corporation	36
iCAST	Atrium Medical Corporation	34
Wallstent™ RP Endoprosthesis	Boston Scientific Corporation	32
Tracheal Stent system (Y-shaped)	Micro-Tech (Nanjing) Co., Ltd.	27
Aero DV®	Merit Medical Systems, Inc.	27
Wallgraft®	Boston Scientific Corporation	25
AEROmini®	Merit Medical Systems, Inc.	25
Through the Scope Tracheal Stent System	Micro-Tech (Nanjing) Co., Ltd.	17
Wallstent® Endoprosthesis	Boston Scientific Corporation	16

Showing 12 of 14. All products under Prosthesis, Tracheal, Expandable

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K891411	1991-12-18

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-Z