AccessGUDID - DEVICE: Ultraflex™ Esophageal NG (08714729716174)

GUDID

Device Identifier (DI) Information

Brand Name: Ultraflex™ Esophageal NG
Version or Model: M00513800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729716174
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Proximal Release 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?
61773	Bare-metal oesophageal stent, non-sterile	A non-sterile, non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures (e.g., from intrinsic/extrinsic malignant tumours) or to reduce acute bleeding from oesophageal varices. It is a mesh structure made entirely of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted and expanded in situ with a balloon catheter, or inserted with a delivery device and self-expand upon release; disposable devices intended to assist implantation may be included.	Obsolete	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: 70 mm Stent Length
Device Size Text, specify: 18 mm Stent Diameter

Device Record Status

Public Device Record Key: 1e79fb84-1865-47ae-8eac-d5a997a2bd38
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015