Catalog Number

-

Brand Name

CSU Baby Balfour

Version/Model Number

1100-611B-SET

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

-

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

FFO

Product Code Name

RETRACTOR, SELF-RETAINING

Public Device Record Key

ef356b74-9515-4e35-a6ab-0a93231b5683

Public Version Date

June 24, 2022

Public Version Number

1

DI Record Publish Date

June 16, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-