Duns Number:041854332
Device Description: 5P NAVY HI PULL W/SLIP ON *O
Catalog Number
300-106
Brand Name
5P NAVY HI PULL W/SLIP ON *O
Version/Model Number
300-106
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
DZB
Product Code Name
Headgear, Extraoral, Orthodontic
Public Device Record Key
383a3b67-ea22-4dae-9949-4f3f89cfda04
Public Version Date
February 02, 2021
Public Version Number
3
DI Record Publish Date
May 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 | 45 |
2 | A medical device with a moderate to high risk that requires special controls. | 183 |