Catalog Number

1540.D

Brand Name

Cryo Probe: Extended Retinal, 2.5mm

Version/Model Number

1540.D

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

K160591

Product Code

HRN

Product Code Name

Unit, Cryophthalmic, Ac-Powered

Public Device Record Key

a3c9012a-412f-4ecc-9abd-03c51b73a752

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-