FDA.reportPublic FDA data

Gianturco-Rosch Cook-Z

Primary DI
00827002085541
Brand
Gianturco-Rosch Cook-Z
Company
COOK INCORPORATED
Model
G08554
Catalog number
GTZS-25-5.0
Device description
Cook-Z Stent Gianturco-Rosch Tracheobronchial Design
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCTProsthesis, tracheal, expandable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCTProsthesis, Tracheal, ExpandableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002085541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002085541008270020855418270020855410827002085541

GMDN Terms#

Term, Definition table
TermDefinition
Trachea prosthesisAn implantable artificial substitute for the natural trachea used in airway reconstructive surgery. It is typically a semi-rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal trachea prosthesis may be uncovered or covered with a polymeric material.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450690765AERO DV®Merit Medical Systems, Inc.JCT2025-06-10
00884450690833AERO DV®Merit Medical Systems, Inc.JCT2024-05-22
00884450690758AERO DV®Merit Medical Systems, Inc.JCT2024-03-30
00884450703991AERO®Merit Medical Systems, Inc.JCT2024-03-27
00884450703960AERO®Merit Medical Systems, Inc.JCT2024-03-26
00884450690796AERO DV®Merit Medical Systems, Inc.JCT2024-03-22
00884450703984AERO®Merit Medical Systems, Inc.JCT2024-03-21
00884450704004AERO®Merit Medical Systems, Inc.JCT2024-03-19
00884450703939AERO®Merit Medical Systems, Inc.JCT2024-03-16
00884450704011AERO®Merit Medical Systems, Inc.JCT2024-03-16
00884450703922AERO®Merit Medical Systems, Inc.JCT2024-03-09
00884450703946AERO®Merit Medical Systems, Inc.JCT2024-03-08
00884450703977AERO®Merit Medical Systems, Inc.JCT2024-03-06
00884450690857AERO DV®Merit Medical Systems, Inc.JCT2024-01-03
00884450690734AERO DV®Merit Medical Systems, Inc.JCT2023-12-16
00884450690864AERO DV®Merit Medical Systems, Inc.JCT2023-12-13
00884450691403AERO DV®Merit Medical Systems, Inc.JCT2023-11-15
00884450690789AERO DV®Merit Medical Systems, Inc.JCT2023-11-10
00884450690840AERO DV®Merit Medical Systems, Inc.JCT2023-10-27
00884450691113AERO®Merit Medical Systems, Inc.JCT2023-10-13
00884450688823AEROmini®Merit Medical Systems, Inc.JCT2023-10-05
00884450690741AERO DV®Merit Medical Systems, Inc.JCT2023-10-05
00884450690819AERO DV®Merit Medical Systems, Inc.JCT2023-10-05
00884450625309AERO®Merit Medical Systems, Inc.JCT2023-09-28
00884450691069AERO®Merit Medical Systems, Inc.JCT2023-09-28
00884450691007AERO®Merit Medical Systems, Inc.JCT2023-09-26
00884450710302AEROmini®Merit Medical Systems, Inc.JCT2023-09-20
00884450624944AERO®Merit Medical Systems, Inc.JCT2023-09-16
00884450688809AEROmini®Merit Medical Systems, Inc.JCT2023-09-16
00884450688885AEROmini®Merit Medical Systems, Inc.JCT2023-09-16