Duns Number:831465641
Device Description: The stainless steel frame is softened by hypo-allergenic chin and forehead pads to minimiz The stainless steel frame is softened by hypo-allergenic chin and forehead pads to minimize irritation and maximize patient acceptance. Bilateral and bi-longitudinal adjust-ability allow for patient customization.Each mask also includes: 1 forehead pad, 2 chin pad and replacement screws.
Catalog Number
-
Brand Name
G&H REVERSE PULL FACE MASK, LARGE
Version/Model Number
RPFMLG
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111169
Product Code
DZB
Product Code Name
Headgear, Extraoral, Orthodontic
Public Device Record Key
af83b1d1-6179-4e9d-bab1-f28874dad474
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 288 |