Duns Number:088480717
Device Description: ATOMO sterilization pouch 3-1/2"x6-1/2"
Catalog Number
-
Brand Name
ATOMO
Version/Model Number
AA0112
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
1be8f7f6-70d1-4789-813d-f65b536c4424
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
January 08, 2018
Package DI Number
D883AA01123
Quantity per Package
30
Contains DI Package
D883AA01121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |