AccessGUDID - DEVICE: AlboGraft Polyester Vascular Graft (00840663102914)

GUDID

Device Identifier (DI) Information

Brand Name: AlboGraft Polyester Vascular Graft
Version or Model: AMC6008
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AMC6008
Company Name: Lemaitre Vascular, Inc.

Primary DI Number: 00840663102914
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 184805166 *Terms of Use

Device Description: AlboGraft Polyester Vascular Graft 60cmx8mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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
MAL	Graft, Vascular, Synthetic/Biologic Composite

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093231	000
K103080	000

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
No Device Sizes

Device Record Status

Public Device Record Key: b6aaf832-d170-40a9-93e4-6ba3cb12a293
Public Version Date: September 24, 2025
Public Version Number: 7
DI Record Publish Date: October 16, 2015