AccessGUDID - DEVICE: WallFlex™ Esophageal (08714729778035)

GUDID

Device Identifier (DI) Information

Brand Name: WallFlex™ Esophageal
Version or Model: M00516700
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729778035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: 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?
61571	Afamin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of afamin, also known as alpha-albumin (previously known as alpha-1-T glycoprotein), in a clinical specimen, using an enzyme immunoassay (EIA) method. Afamin has been associated with metabolic syndrome, insulin resistance and ovarian cancer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ESW	PROSTHESIS, ESOPHAGEAL

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: No
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: 103 mm Stent Length
Device Size Text, specify: 18 mm Stent Diameter

Device Record Status

Public Device Record Key: b18f670a-bd3a-4f59-9b66-22f8564f9869
Public Version Date: June 18, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2015