Duns Number:830016148
Device Description: 3M™ Durapore™ Advanced Surgical Tape 3 inches x 10 yards 4 Rolls/Carton 10 Cartons/Case 15 3M™ Durapore™ Advanced Surgical Tape 3 inches x 10 yards 4 Rolls/Carton 10 Cartons/Case 1591-3
Catalog Number
1591-3
Brand Name
3M™ Durapore™
Version/Model Number
1591-3
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
ae3199e1-f48f-49c7-a4c1-f80212f4825a
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
04054596476011
Quantity per Package
10
Contains DI Package
04054596476004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CTNS
| 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 |