Catalog Number

EFD140ACS

Brand Name

FRIGI-DENT

Version/Model Number

EFD140ACS

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

-

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

K954703,K954703

Product Code

GEH

Product Code Name

UNIT, CRYOSURGICAL, ACCESSORIES

Public Device Record Key

9a24e6fa-b114-4625-b5fb-358003b01669

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

10841494105133

Quantity per Package

25

Contains DI Package

00841494103217

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-