Catalog Number

S-CO2-16G-BOX

Brand Name

Accurett

Version/Model Number

16g CO2 cartridges

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K161615,K161615,K161615

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

3b14a45b-92d5-46db-bd88-bef5c19b7a5b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

B386SCO216GCARTON2

Quantity per Package

12

Contains DI Package

B386SCO216GBOX1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-