Catalog Number

-

Brand Name

Center Focus Handle

Version/Model Number

B1-530-40

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FTA

Product Code Name

Light, Surgical, Accessories

Public Device Record Key

2eaf7a28-16e3-4b72-8198-bd3d7a3281fb

Public Version Date

February 23, 2022

Public Version Number

1

DI Record Publish Date

February 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-