DURAGLIDE - DURAGLIDE STONE BALLOON 15MM, ABOVE - Conmed Corporation

Duns Number:071595540

Device Description: DURAGLIDE STONE BALLOON 15MM, ABOVE

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More Product Details

Catalog Number

007125

Brand Name

DURAGLIDE

Version/Model Number

007125

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K993892

Product Code Details

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Device Record Status

Public Device Record Key

16d2298e-053c-43d9-9aca-903917f50958

Public Version Date

November 19, 2020

Public Version Number

5

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95