AccessGUDID - DEVICE: WALLSTENT® Endoprosthesis (08714729204084)

GUDID

Device Identifier (DI) Information

Brand Name: WALLSTENT® Endoprosthesis
Version or Model: H965404130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H965404130
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729204084
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?
43589	Bare-metal tracheal/bronchial stent	A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. It may be a straight or branched mesh structure, or continuous tube, and is made of metal [e.g., high-grade stainless steel, nickel-titanium alloy (Nitinol)]. It is typically expandable in situ (e.g., with a balloon catheter or is self-expandable); disposable devices intended to assist implantation may be included with the stent.	Active	true
35458	Trachea prosthesis	An implantable artificial substitute for the natural trachea used in airway reconstructive surgery. It is typically a semi-rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal trachea prosthesis may be uncovered or covered with a polymeric material.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JCT	Prosthesis, tracheal, expandable

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 18 mm Stent Diameter
Device Size Text, specify: 90 mm Stent Length
Device Size Text, specify: 75 cm Effective Length

Device Record Status

Public Device Record Key: 28390cb0-34b3-4cdd-ade9-ef91aae90283
Public Version Date: December 20, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2015