Duns Number:015108087
Device Description: SOLEIL PROTECTIVE HANDSHIELD
Catalog Number
-
Brand Name
SOLEIL
Version/Model Number
5128-185
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
EBZ
Product Code Name
Activator, Ultraviolet, For Polymerization
Public Device Record Key
697fc523-cf96-4c66-956c-84cce6a3ea1c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 02, 2017
Package DI Number
D74451281851
Quantity per Package
100
Contains DI Package
D74451281850
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1364 |
2 | A medical device with a moderate to high risk that requires special controls. | 377 |
U | Unclassified | 15 |