Duns Number:830016148
Device Description: Nexcare™ Durapore™ Cloth Tape, 538-P1, 1 in x 10 yds, Rolled
Catalog Number
538-P1
Brand Name
3M™ Nexcare™ Durapore™
Version/Model Number
538-P1
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
-
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
dd6e03f7-cc47-4280-a112-184b83df00b9
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
September 25, 2018
Package DI Number
50051131000204
Quantity per Package
3
Contains DI Package
30051131000200
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |