Duns Number:034824691
Device Description: Klarity Light Green O-Type Head Mask, 2.4mm, Perf 12%, 3 Point, With Nose Hole, Rounded Ne Klarity Light Green O-Type Head Mask, 2.4mm, Perf 12%, 3 Point, With Nose Hole, Rounded Neck, Smooth Edge. Compatible with Klarity and Orfit Baseplates.
Catalog Number
-
Brand Name
Klarity Medical
Version/Model Number
RDLG107-2412C
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
K022708
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
4440ce95-9637-46e0-94a2-9db07f54ed03
Public Version Date
September 16, 2020
Public Version Number
4
DI Record Publish Date
March 21, 2017
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. | 483 |