Catalog Number

-

Brand Name

27ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Nidek

Version/Model Number

V6300-27ER

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

63bc8b46-98ea-469e-9851-8fd91246eb9c

Public Version Date

October 06, 2020

Public Version Number

1

DI Record Publish Date

September 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-