ELIMINATOR - 8MM X 3CM PET BILIARY BALLOON DILATOR - Conmed Corporation

Duns Number:071595540

Device Description: 8MM X 3CM PET BILIARY BALLOON DILATOR

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More Product Details

Catalog Number

000349

Brand Name

ELIMINATOR

Version/Model Number

000349

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2021

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

K920361

Product Code Details

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Device Record Status

Public Device Record Key

e0e2fe23-d387-4aff-8be2-558f48c2cdec

Public Version Date

September 01, 2021

Public Version Number

4

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