Catalog Number

350-8600

Brand Name

B.BRAUN

Version/Model Number

350-8600

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

9006432e-ea9a-4528-ad7e-7a2e883d6f50

Public Version Date

May 24, 2021

Public Version Number

1

DI Record Publish Date

May 15, 2021

Package DI Number

04046955696284

Quantity per Package

6

Contains DI Package

04046955696277

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton