Duns Number:023904428
Device Description: Face Shield FULL LENGTH (9.5”) ANTI-FOG DIRECT SPLASH PROTECTION SPLASH GUARD ONLY SAF Face Shield FULL LENGTH (9.5”) ANTI-FOG DIRECT SPLASH PROTECTION SPLASH GUARD ONLY SAFETY SHIELD NON-STERILE
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-1295
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
For Single-Use
Yes
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
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
93bc2569-84b0-4b99-99ce-530d8c5755e4
Public Version Date
May 06, 2020
Public Version Number
1
DI Record Publish Date
April 28, 2020
Package DI Number
00612479217393
Quantity per Package
25
Contains DI Package
00612479217386
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |