Catalog Number

7M2804

Brand Name

B.BRAUN

Version/Model Number

7M2804

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)

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

df4b890e-e6b3-4669-8dae-73e8d8036d57

Public Version Date

September 23, 2019

Public Version Number

3

DI Record Publish Date

July 24, 2017

Package DI Number

04046964350009

Quantity per Package

6

Contains DI Package

04046964823749

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton