Duns Number:315731711
Device Description: 3M™ Durapore™ Surgical Tape, 1548S-2, 2 in x 1.5 yd (5 cm x 1.37 m), Packaged, 50 Rolls/Ba 3M™ Durapore™ Surgical Tape, 1548S-2, 2 in x 1.5 yd (5 cm x 1.37 m), Packaged, 50 Rolls/Bag, 5 Bags/Case
Catalog Number
1548S-2
Brand Name
3M™ Durapore™
Version/Model Number
1548S-2
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
2b725056-7bb4-4655-af32-e32df6865df2
Public Version Date
February 01, 2021
Public Version Number
1
DI Record Publish Date
January 22, 2021
Package DI Number
50707387792607
Quantity per Package
5
Contains DI Package
00707387792602
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 | 232 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 563 |
| U | Unclassified | 3 |