Duns Number:839138955
Device Description: AED OTOSCOPE W/ SHEATH
Catalog Number
-
Brand Name
AED
Version/Model Number
8840A-XS
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"
Yes
For Single-Use
-
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
ERA
Product Code Name
OTOSCOPE
Public Device Record Key
ed54b997-5675-4c4b-b560-c93159a548ad
Public Version Date
June 05, 2019
Public Version Number
1
DI Record Publish Date
May 28, 2019
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 | 579 |
2 | A medical device with a moderate to high risk that requires special controls. | 6418 |