Duns Number:071595540
Device Description: STRIP-N-TAPE, ADHESIVE TAPE STRIP
Catalog Number
701-0510
Brand Name
STRIP-N-TAPE
Version/Model Number
701-0510
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMK
Product Code Name
DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Public Device Record Key
632abdaf-4ca1-489e-9ed6-698144fdf579
Public Version Date
December 21, 2020
Public Version Number
1
DI Record Publish Date
December 13, 2020
Package DI Number
20653405014222
Quantity per Package
1000
Contains DI Package
10653405014225
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |