Duns Number:800777117
Device Description: To remove adhesive tape from skin.
Catalog Number
B16400
Brand Name
PDI® Adhesive Tape Remover Pad
Version/Model Number
B16400
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
KOX
Product Code Name
Solvent, Adhesive Tape
Public Device Record Key
6bf0f31c-d9e3-4c1f-bbb5-fd230102619a
Public Version Date
August 11, 2020
Public Version Number
1
DI Record Publish Date
August 03, 2020
Package DI Number
10310819000458
Quantity per Package
100
Contains DI Package
00310819000451
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 | 3 |
U | Unclassified | 1 |