Duns Number:112853395
Device Description: Sold in Box of 24.Full face shield with anti-fog coat, comfort foam band, stretch strap Sold in Box of 24.Full face shield with anti-fog coat, comfort foam band, stretch strap
Catalog Number
-
Brand Name
SHIELD SECURE
Version/Model Number
1010-1017
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
29686b10-1793-4f40-9a03-10c78de19ab5
Public Version Date
April 06, 2020
Public Version Number
2
DI Record Publish Date
October 16, 2019
Package DI Number
20048329000350
Quantity per Package
12
Contains DI Package
10048329000353
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER SHIP CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |