Duns Number:315427286
Device Description: J-Hooks for Hickham headgear, with sliding tubes and elastics
Catalog Number
-
Brand Name
N.A.
Version/Model Number
744-713-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 06, 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"
-
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
K936151,K936151
Product Code
DZB
Product Code Name
Headgear, extraoral, orthodontic
Public Device Record Key
e5cd5a01-2ba2-4a72-a556-ea605ee6afdd
Public Version Date
October 06, 2021
Public Version Number
4
DI Record Publish Date
September 15, 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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1745 |