AccessGUDID - DEVICE: Supera™ (08717648344275)

GUDID

Device Identifier (DI) Information

Brand Name: Supera™
Version or Model: S-70-080-120-P6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S-70-080-120-P6
Company Name: ABBOTT VASCULAR INC.

Primary DI Number: 08717648344275
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964569052 *Terms of Use

Device Description: Supera™ Peripheral Stent System 7.0 mm x 80 mm x 120 cm 6 F

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?
47932	Peripheral artery stent, bare-metal	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIP	STENT, SUPERFICIAL FEMORAL ARTERY

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
Special Storage Condition, Specify: Keep away from Direct Sunlight,Keep Dry.

Clinically Relevant Size

[?]

Size Type Text
Stent Diameter: 7 Millimeter
Stent Length: 80 Millimeter

Device Record Status

Public Device Record Key: ff5ad0ef-4e17-4879-a64a-53151b4f3568
Public Version Date: December 11, 2024
Public Version Number: 5
DI Record Publish Date: August 25, 2021