WALLGRAFT®

Basic Information

• Brand Name: WALLGRAFT®
• Primary DI: 08714729283379
• Version / Model: M001705730
• Catalog Number: M001705730
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e7fd265b-2d07-4da4-b27e-1c6c43289209

Device Description

Tracheobronchial Endoprosthesis

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JCT	Prosthesis, tracheal, expandable	General, Plastic Surgery	878.3720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729283379	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			90 cm Effective Length
Device Size Text, specify			30 mm Stent Length
Device Size Text, specify			7 mm Stent Diameter