Duns Number:001403807
Catalog Number
-
Brand Name
E.M. Adams, Inc.
Version/Model Number
14 60108
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 18, 2021
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHG
Product Code Name
Circumcision Tray
Public Device Record Key
fe5d7609-8ae9-433b-b519-4c56dbf380fd
Public Version Date
June 21, 2021
Public Version Number
3
DI Record Publish Date
August 18, 2016
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 | 1447 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |