AccessGUDID - DEVICE: DURAGLIDE (00653405053708)

GUDID

Device Identifier (DI) Information

Brand Name: DURAGLIDE
Version or Model: 007123
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 007123
Company Name: Conmed Corporation

Primary DI Number: 00653405053708
Issuing Agency: GS1
Commercial Distribution End Date: October 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: DURAGLIDE STONE BALLOON 8.5MM, ABOVE

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):	Yes
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?
46715	ERCP catheter, balloon, non-electrical, stone-retrieval	A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGE	CATHETER, BILIARY, DIAGNOSTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993892	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 8.5 Millimeter

Device Record Status

Public Device Record Key: e8cb20e7-80be-4ca7-b7f4-37222a2527ed
Public Version Date: November 19, 2020
Public Version Number: 5
DI Record Publish Date: October 24, 2015