Duns Number:830016148
Device Description: 3M™ Durapore™ D Surgical Tape, 1538-1D, 1 in x 10 yd (2,5 cm x 9,1 m), 12 Rolls/Carton, 10 3M™ Durapore™ D Surgical Tape, 1538-1D, 1 in x 10 yd (2,5 cm x 9,1 m), 12 Rolls/Carton, 10 Cartons/Case
Catalog Number
1538-1D
Brand Name
3M™ Durapore™
Version/Model Number
1538-1D
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
fb017f04-f405-4984-9015-468d2e672694
Public Version Date
January 18, 2021
Public Version Number
1
DI Record Publish Date
January 08, 2021
Package DI Number
50707387793345
Quantity per Package
10
Contains DI Package
00707387793340
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |