AccessGUDID - DEVICE: AlboGraft Polyester Vascular Graft (00840663110384)

GUDID

Device Identifier (DI) Information

Brand Name: AlboGraft Polyester Vascular Graft
Version or Model: ATC1206
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ATC1206
Company Name: Lemaitre Vascular, Inc.

Primary DI Number: 00840663110384
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® Woven with Collagen Bifurcated 12mm x 6mm x 50cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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
Storage Environment Temperature: between 0 and 30 Degrees Celsius
Special Storage Condition, Specify: keep away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f926348e-2512-464f-81d5-1bedb1e4d586
Public Version Date: September 24, 2025
Public Version Number: 3
DI Record Publish Date: June 18, 2021