Hollister - Urostomy Drain Tube Adapter - HOLLISTER INCORPORATED

Duns Number:005527098

Device Description: Urostomy Drain Tube Adapter

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More Product Details

Catalog Number

-

Brand Name

Hollister

Version/Model Number

7331

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

EXB

Product Code Name

COLLECTOR, OSTOMY

Device Record Status

Public Device Record Key

624d08bd-fd2b-4fc7-b29e-655bc9b6b2ff

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

January 01, 2018

Additional Identifiers

Package DI Number

20610075073317

Quantity per Package

24

Contains DI Package

00610075073313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HOLLISTER INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 30