AccessGUDID - DEVICE: AlboGraft Polyester Vascular Graft (00840663110360)

GUDID

Device Identifier (DI) Information

Brand Name: AlboGraft Polyester Vascular Graft
Version or Model: ATC6034
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ATC6034
Company Name: Lemaitre Vascular, Inc.

Primary DI Number: 00840663110360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184805166 *Terms of Use

Device Description: AlboGraft® Woven with Collagen 34mm x 60cm

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 the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.	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: 57f2908f-3790-4fd2-90b5-0e7d8ab22609
Public Version Date: June 28, 2021
Public Version Number: 1
DI Record Publish Date: June 18, 2021