Duns Number:108999095
Device Description: ADSAFE Face Shield Plus,Adult, w/keychain, White
Catalog Number
4056W
Brand Name
Adsafe™
Version/Model Number
4056W
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 12, 2017
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)
-
Over the Counter (OTC)
Yes
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
720d39f1-c2cd-4645-a8cc-dd4e19c2121b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
00634782555092
Quantity per Package
10
Contains DI Package
00634782855093
Package Discontinue Date
September 12, 2017
Package Status
Not in Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |