Catalog Number

FAS3000000

Brand Name

PROSENSE™ SYSTEM 100-127 VAC

Version/Model Number

FAS3000000

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

-

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

K183213

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

0c731b7b-9a69-4cff-86cb-643db32d2f1d

Public Version Date

June 02, 2022

Public Version Number

3

DI Record Publish Date

October 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-