Duns Number:831465641
Device Description: Our Safety Release Modules are available in 3 force ranges to provide dependable retractio Our Safety Release Modules are available in 3 force ranges to provide dependable retraction. The specially designed retention clip releases at 4 to 5 lbs. of outward force for patient safety.
Catalog Number
-
Brand Name
G&H SAFETY RELEASE MODULE, 600 GR
Version/Model Number
SR**600
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
-
Product Code
DZB
Product Code Name
Headgear, Extraoral, Orthodontic
Public Device Record Key
34489510-d814-4d0b-9c4d-26a860e2e6a2
Public Version Date
March 29, 2018
Public Version Number
2
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 |