Catalog Number

-

Brand Name

BV Medical

Version/Model Number

60-425-220

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYT

Product Code Name

Light, Examination, Medical, Battery Powered

Public Device Record Key

5188a1ca-8ce4-4380-bd57-1b70cd7b2222

Public Version Date

October 04, 2018

Public Version Number

1

DI Record Publish Date

September 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-