AccessGUDID - DEVICE: Autoinjector 2 (00850007370398)

GUDID

Device Identifier (DI) Information

Brand Name: Autoinjector 2
Version or Model: TV-AI01-N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TV-AI01-N
Company Name: Endologix, Inc.

Primary DI Number: 00850007370398
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 179593652 *Terms of Use

Device Description: "The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjector 2 applies controlled force to the syringe plunger of the CustomSeal Kit to inject the fill polymer into the graft until pressure equilibrium is reached and complete fill of the primary sealing ring, fill channels, and support rings in the graft material the of the aortic body is achieved."

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 [?]
P120006	031

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 a cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f440b4cd-3b3c-49b4-bf0d-8b7997accf7e
Public Version Date: December 11, 2024
Public Version Number: 2
DI Record Publish Date: February 28, 2023