AccessGUDID - DEVICE: AFX2 Bifurcated Endograft System (00818009015082)

GUDID

Device Identifier (DI) Information

Brand Name: AFX2 Bifurcated Endograft System
Version or Model: BEA22-110/I20-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENDOLOGIX, INC.

Primary DI Number: 00818009015082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 858560477 *Terms of Use

Device Description: No description.

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	Abdominal aorta 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 typically made of a metallic outer mesh structure with an inner 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 [?]
P040002	055
P040002	056

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 30 mm, Limb Length
Device Size Text, specify: 20 mm, Limb Diameter
Device Size Text, specify: 110 mm, Main Body Length
Device Size Text, specify: 22 mm, Main Body Diameter

Device Record Status

Public Device Record Key: 92ceaccc-70e4-4f97-b7a1-b79c5cde6e63
Public Version Date: December 11, 2024
Public Version Number: 9
DI Record Publish Date: January 18, 2016