Catalog Number

-

Brand Name

Single Use Retinal Cryo Probe (Box of 10 Probes)

Version/Model Number

2509-P-8033

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

-

Product Code

HRN

Product Code Name

Unit, Cryophthalmic, Ac-Powered

Public Device Record Key

fc65a0d2-5df8-4c63-bb68-246bb8bcd12d

Public Version Date

November 17, 2020

Public Version Number

1

DI Record Publish Date

November 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-