BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Zenith TX2 Pro-Form

DI: 10827002534787 · Model: G53478 · William Cook Europe ApS

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Zenith TX2 Pro-Form
Primary DI: 10827002534787
Version / Model: G53478
Catalog Number: ZTEG-2D-34-136-PF-US
Company Name: William Cook Europe ApS
Labeler DUNS: 305302119
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2014-09-24
Public Version: 7
Public Version Date: 2025-12-25
Public Version Status: Update
Public Device Record Key: a4d32f74-ff29-4374-8aeb-192246e2ce7f
Distribution End Date: 2019-09-25

Device Description

Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Conditional
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIH	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35281	Synthetic vascular graft, non-medicated	An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10827002534787	GS1

Customer Contacts

Phone: +1(812)330-5494
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P070016	001
P070016	002
P070016	003
P070016	004
P070016	005
P070016	006
P070016	007

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Store in dark, dry, cool place.