Duns Number:010016319
Device Description: Pro-Tek-To Pad, Shimmering Navy Blue
Catalog Number
-
Brand Name
Pro-Tek-To Pad
Version/Model Number
75057-40
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
-
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
68229fa7-63d8-46a7-b4a2-644d961b8950
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
August 07, 2020
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 | 3215 |