Catalog Number

S-CO2-16G-BOX

Brand Name

Accurett®

Version/Model Number

16g cartridges for Accurett

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

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

5b6e073f-75b9-429d-9795-d4e211b52d5e

Public Version Date

September 29, 2021

Public Version Number

1

DI Record Publish Date

September 21, 2021

Package DI Number

25407008486109

Quantity per Package

12

Contains DI Package

15407008486102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-