Catalog Number

0015850

Brand Name

Davol Bile Bag, Regular

Version/Model Number

0015850

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

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

-

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

15a36462-2797-486b-9479-e42d82f3b639

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 29, 2015

Package DI Number

10801741011617

Quantity per Package

12

Contains DI Package

00801741011610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA