Catalog Number

7M2802

Brand Name

B.BRAUN

Version/Model Number

7M2802

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"

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

LCJ

Product Code Name

EXPANDER, SKIN, INFLATABLE

Public Device Record Key

be165232-6c1e-4a1f-84be-8138126c88aa

Public Version Date

April 19, 2021

Public Version Number

5

DI Record Publish Date

October 11, 2015

Package DI Number

04046964349928

Quantity per Package

10

Contains DI Package

04046964787102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton