AccessGUDID - DEVICE: EndoVive One Step Button (08714729284208)

GUDID

Device Identifier (DI) Information

Brand Name: EndoVive One Step Button
Version or Model: M00563080
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729284208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Low Profile Percutaneous Endoscopic Gastrostomy Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
Combination Product:	Yes
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?
64463	Gastrostomy tube kit, medicated	A collection of devices which includes a gastrostomy tube with a pharmaceutical agent intended for short- and/or long-term (= 24 hours) access to the stomach via a gastrostomy. In addition to the gastrostomy tube and a pharmaceutical agent, the kit includes additional invasive devices designed to perform the gastrostomy and/or assist tube introduction (e.g., scalpel, introduction needle, stoma sizer, guidewire, dilator). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGC	TUBE, GASTRO-ENTEROSTOMY

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: 8.0 mm Diameter
Device Size Text, specify: 2.4 cm Length
Device Size Text, specify: 24 F Diameter

Device Record Status

Public Device Record Key: 1620807e-4fb7-427e-b3b5-2b061b2dcc64
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016