Catalog Number

FAP7910000

Brand Name

Cryoprobe D3.4 mm/10G, 285 mm, Pencil, Elliptic.

Version/Model Number

FAP7910000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 02, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

ea7e4f3f-dd99-4d90-8caf-1f37122d3487

Public Version Date

June 08, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-