AccessGUDID - DEVICE: Epic™ Vascular (08714729805854)

GUDID

Device Identifier (DI) Information

Brand Name: Epic™ Vascular
Version or Model: H74939200097070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H74939200097070
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729805854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Self-Expanding Stent System

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?
44279	Iliac artery stent, bare-metal	A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NIO	STENT, ILIAC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P110035	000
P110035	012
P110035	032
P110035	036

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 75 cm Effective Length
Device Size Text, specify: 70 mm Stent Length
Device Size Text, specify: 9 mm Stent Diameter

Device Record Status

Public Device Record Key: 58becb60-9846-45d1-84dd-b2fb9825309b
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2014