Catalog Number

CRYO-48-F

Brand Name

8mm Cryoprobe

Version/Model Number

DP35-0215-102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K011074

Product Code

OCL

Product Code Name

Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Public Device Record Key

aa75ecb0-1b77-4477-aa3a-2f711aec84ef

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-