AccessGUDID - DEVICE: Zenith TX2 Pro-Form (10827002534497)

GUDID

Device Identifier (DI) Information

Brand Name: Zenith TX2 Pro-Form
Version or Model: G53449
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ZTEG-2PT-38-202-PF-US
Company Name: William Cook Europe ApS

Primary DI Number: 10827002534497
Issuing Agency: GS1
Commercial Distribution End Date: September 25, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 305302119 *Terms of Use

Device Description: Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35281	Synthetic vascular graft	An implantable artificial substitute for a blood vessel intended to replace or bypass a diseased or injured vessel, typically the aorta, an iliac, a femoral or popliteal artery; it is not intended for use in the coronary arteries. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics; it does not incorporate a metallic mesh (i.e., it is not a stent-graft).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIH	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P070016	001
P070016	002
P070016	003
P070016	004
P070016	005
P070016	006
P070016	007

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dark, dry, cool place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8c908c3f-cb91-4aca-bb33-aa03aa112288
Public Version Date: September 24, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2014