AccessGUDID - DEVICE: Carotid WALLSTENT® (08714729781202)

GUDID

Device Identifier (DI) Information

Brand Name: Carotid WALLSTENT®
Version or Model: M001719020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M001719020
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729781202
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Closed Cell 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?
45851	Bare-metal carotid artery stent	A non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIM	STENT, CAROTID

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P050019	000
P050019	001
P050019	004
P050019	006
P050019	008
P050019	021
P050019	035

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: 135 cm Effective Length
Device Size Text, specify: 29 mm Stent Length
Device Size Text, specify: 8 mm Stent Diameter

Device Record Status

Public Device Record Key: 4f64e59a-2f59-4cd7-9840-f4f222979f88
Public Version Date: April 17, 2023
Public Version Number: 6
DI Record Publish Date: March 24, 2015