AccessGUDID - DEVICE: DURAGLIDE (20653405053795)

GUDID

Device Identifier (DI) Information

Brand Name: DURAGLIDE
Version or Model: 000646
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 000646
Company Name: Conmed Corporation

Primary DI Number: 20653405053795
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: DURAGLIDE Stone Balloon, 11.5mm, 7-5f

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
GCA	CATHETER, BILIARY, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K920342	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 11.5 Millimeter Balloon Outer Diameter
Device Size Text, specify: 200 Centimeter Catheter Length
Device Size Text, specify: 0.035 Inch Wire Outer Diameter
Device Size Text, specify: 1.5 Milliliter Balloon Maximum Inflation Volume
Device Size Text, specify: 7 - 5 French Catheter Outer Diameter
Device Size Text, specify: .89 Millimeter Wire Outer Diameter
Device Size Text, specify: 2.3 - 1.7 Millimeter Catheter Outer Diameter

Device Record Status

Public Device Record Key: 6800f540-7522-421d-8083-14a9b59a2f2d
Public Version Date: June 07, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)237-0169
Email: CUSTOMER_SERVICE@CONMED.COM

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES