Catalog Number

-

Brand Name

ATOMO

Version/Model Number

AA0111

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

K071886,K071886,K071886

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

daa2af2e-1677-4e44-9fd0-1abd8fd0a955

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

January 08, 2018

Package DI Number

D883AA01113

Quantity per Package

20

Contains DI Package

D883AA01111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton