Catalog Number

-

Brand Name

23ga Straight Laser Probe

Version/Model Number

620201

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121187,K121187

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Public Device Record Key

0519c211-ec1e-4f2d-9a43-c5138bcbbdb0

Public Version Date

March 12, 2020

Public Version Number

1

DI Record Publish Date

March 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-