Duns Number:658122049
Device Description: Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #3 Silicone mask with PSF dome for Large ChildHeadstar offers anatomically designed face mask that brings maximum comfort to the patient.
Catalog Number
-
Brand Name
HEADSTAR
Version/Model Number
HS-8803
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
-
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
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
943f843d-9422-4f4e-9b2f-a6f2740f80f2
Public Version Date
June 04, 2020
Public Version Number
1
DI Record Publish Date
May 27, 2020
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |