Duns Number:083171244
Device Description: Flow Regulator intended to be used with MicroMyst® Applicator. It's intended to provide pr Flow Regulator intended to be used with MicroMyst® Applicator. It's intended to provide pressurized gas (air or nitrogen) to Integra gas-assisted applicators.
Catalog Number
FR6065
Brand Name
Integra®
Version/Model Number
FR6065
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
-
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
CAN
Product Code Name
Regulator, Pressure, Gas Cylinder
Public Device Record Key
75c74832-8e62-4464-9e24-49db3cf6b0fa
Public Version Date
October 05, 2022
Public Version Number
7
DI Record Publish Date
June 05, 2015
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |