Duns Number:078573265
Device Description: Aide To Extraction (ATOE), made of stainless steel. Used in extracting follicles after bei Aide To Extraction (ATOE), made of stainless steel. Used in extracting follicles after being punches.
Catalog Number
380.000
Brand Name
ATOE-Stainless Steel
Version/Model Number
ATOE-Stainless Steel
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HRQ
Product Code Name
Hemostat
Public Device Record Key
feb8fb03-de43-4581-83e7-7b99e4a493a4
Public Version Date
August 05, 2022
Public Version Number
1
DI Record Publish Date
July 28, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 75 |