Catalog Number

-

Brand Name

ACCUSEAL

Version/Model Number

027060

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)

-

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

EXH

Product Code Name

BAG, URINARY, ILEOSTOMY

Public Device Record Key

130c000c-42e3-4047-98b9-0c769e440c44

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

10768455109132

Quantity per Package

1

Contains DI Package

00768455109135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-