AccessGUDID - DEVICE: ADVANTA SLIDER GDS (00650862222326)

GUDID

Device Identifier (DI) Information

Brand Name: ADVANTA SLIDER GDS
Version or Model: 22232
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Atrium Medical Corporation

Primary DI Number: 00650862222326
Issuing Agency: GS1
Commercial Distribution End Date: February 13, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 051798999 *Terms of Use

Device Description: 6MMX100CM, TW, H, ADVANTA,VXT, GDS

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 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
DSY	PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f87ad7e4-97e9-4e64-8e76-bd107b07c06d
Public Version Date: April 24, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2015