AccessGUDID - DEVICE: VENOUS WALLSTENT™ (08714729979517)

GUDID

Device Identifier (DI) Information

Brand Name: VENOUS WALLSTENT™
Version or Model: H74912044142070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H74912044142070
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729979517
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

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?
63844	Bare-metal tracheal/bronchial/vascular stent	A non-bioabsorbable, tubular device intended to be implanted to indefinitely maintain patency/improve luminal diameter of a blood vessel (peripheral artery and/or vein) and, alternatively, the tracheobronchial tree; it may in addition be intended to be used in the biliary tract. It is not intended for implantation in a coronary or cerebral artery and not intended for shunting. It is a tubular bare-metal mesh implanted with a balloon catheter or delivery device (balloon and/or self-expanding). It is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QAN	Stent, iliac vein

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980033	050

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
Catheter Length: 75 Centimeter
Stent Length: 20 Millimeter
Stent Diameter: 14 Millimeter

Device Record Status

Public Device Record Key: ff0f7e24-6b36-487a-9f31-7a240977c920
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: March 30, 2020