Duns Number:283679900
Device Description: 5pt H&N&S Mask -No Nose Hole
Catalog Number
-
Brand Name
Orfit Industries
Version/Model Number
35791/2MA/NH/NP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K991319
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
a653ba68-52dc-450a-b683-bb4190024d70
Public Version Date
November 01, 2022
Public Version Number
3
DI Record Publish Date
May 08, 2018
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 78 |