Duns Number:315731711
Device Description: 3M™ Durapore™ Surgical Tape, 1538-118, 1 in x 18 in, Bulk, 800 Rolls/Case
Catalog Number
1538-118
Brand Name
3M™ Durapore™
Version/Model Number
1538-118
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
ddf9fd60-b709-462a-a56f-b2a34c93cdcd
Public Version Date
January 18, 2021
Public Version Number
1
DI Record Publish Date
January 08, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |