Duns Number:044668515
Device Description: HIGH PULL RELEASE MODULE - EAGLEWEAR CLEAR 10/PKG
Catalog Number
852-828
Brand Name
Eaglewear
Version/Model Number
852-828
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZB
Product Code Name
Headgear, Extraoral, Orthodontic
Public Device Record Key
2db47fe3-a0ed-45e8-a897-3f671bd9af01
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
December 07, 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 | 16634 |
2 | A medical device with a moderate to high risk that requires special controls. | 982 |