Duns Number:621134084
Device Description: Multi-purpose shield provides excellent protection during many types of procedures. Provid Multi-purpose shield provides excellent protection during many types of procedures. Provides a comprehensive zone of protection for the head, hands and body of the entire team.
Catalog Number
-
Brand Name
SecureShield© Multipurpose 12" x 36" Scatter Reducing Drape
Version/Model Number
SS-5100-XL
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KPY
Product Code Name
Shield, Protective, Personnel
Public Device Record Key
a7f68d5f-2267-4690-83cb-09a23ab8da09
Public Version Date
September 06, 2022
Public Version Number
1
DI Record Publish Date
August 29, 2022
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 | 107 |