Duns Number:790776850
Catalog Number
-
Brand Name
American Eagle Instruments
Version/Model Number
AERE4563
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
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
-
Product Code
EMJ
Product Code Name
ELEVATOR, SURGICAL, DENTAL
Public Device Record Key
c7c47e3b-7abc-4eca-8133-123c7b8afe8e
Public Version Date
October 05, 2022
Public Version Number
3
DI Record Publish Date
May 23, 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 | 1253 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |