Latex-free Biliary Catherter - Removal of stones and ductal debris from the - APPLIED MEDICAL RESOURCES CORPORATION

Duns Number:187129135

Device Description: Removal of stones and ductal debris from the biliary system.

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More Product Details

Catalog Number

-

Brand Name

Latex-free Biliary Catherter

Version/Model Number

CB062313

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

-

Product Code Details

Product Code

FGE

Product Code Name

Catheter, Biliary, Diagnostic

Device Record Status

Public Device Record Key

eb1118c3-cb43-4558-97ee-75fcd12ba387

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

July 20, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"APPLIED MEDICAL RESOURCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 499
2 A medical device with a moderate to high risk that requires special controls. 698
3 A medical device with high risk that requires premarket approval 1