Catalog Number

10-8020OM

Brand Name

Bosma Enterprises

Version/Model Number

10-8020OM

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

PWU

Product Code Name

Clean-Up Kit

Public Device Record Key

b02c0d65-e5c0-4990-8848-c4ce851f6734

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Package DI Number

10818634020595

Quantity per Package

20

Contains DI Package

00818634020598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case