Catalog Number

-

Brand Name

NA

Version/Model Number

B508504

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K142830,K142830

Product Code

HQB

Product Code Name

Photocoagulator And Accessories

Public Device Record Key

1c305d3c-e241-46dd-a1ed-9a0c2e1a25cf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 09, 2018

Package DI Number

M735B5085045

Quantity per Package

10

Contains DI Package

M735B5085041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-