Catalog Number

BL5827D

Brand Name

Synergetics

Version/Model Number

BL5827D

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

HJM

Product Code Name

Transilluminator, ac-powered

Public Device Record Key

dbc6b2d1-a22d-4afb-ae34-a6f5430adb0b

Public Version Date

June 08, 2020

Public Version Number

1

DI Record Publish Date

May 31, 2020

Package DI Number

20841305112142

Quantity per Package

6

Contains DI Package

10841305112138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box