AccessGUDID - DEVICE: TALENT™ ABDOMINAL (00613994542601)

GUDID

Device Identifier (DI) Information

Brand Name: TALENT™ ABDOMINAL
Version or Model: AF2614C155XH
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994542601
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: STENT GRAFT AF2614C155XH BIFURTALENT AAA

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?
46777	Aortoiliac endovascular stent-graft	A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.	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 [?]
P070027	006

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 at room temperature in a dark, dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Stent Graft Proximal Diameter 26 MM
Device Size Text, specify: Stent Graft Covered Length 155 MM
Device Size Text, specify: Stent Graft Distal Diameter 14 MM

Device Record Status

Public Device Record Key: 1d106106-2e7e-4ae4-a32b-2b36fecfcc48
Public Version Date: September 24, 2025
Public Version Number: 10
DI Record Publish Date: September 23, 2014