AccessGUDID - DEVICE: EverFlex™ Protégé™ EverFlex™ (00821684060186)

GUDID

Device Identifier (DI) Information

Brand Name: EverFlex™ Protégé™ EverFlex™
Version or Model: PRB35-08-020-120
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EV3, INC

Primary DI Number: 00821684060186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117446916 *Terms of Use

Device Description: STENT PRB35-08-020-120 PROTEGE EF V07

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 [?]
P110023	007
P110023	029

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 sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Length: 20.0 Millimeter
Catheter Gauge: 6.0 French

Device Record Status

Public Device Record Key: a4574106-ed1f-4162-9fca-8a14dcab98ff
Public Version Date: December 11, 2024
Public Version Number: 9
DI Record Publish Date: February 16, 2016