Duns Number:005083209
Device Description: TipStop is a compressive dressing made of a polyamide compressive element covered with alg TipStop is a compressive dressing made of a polyamide compressive element covered with alginate, placed on adhesive film. TipStop has been specially designed to stop bleeding after venipuncture. TipStop is sterilised by irradiation. This product is not made with natural rubber latex.
Catalog Number
114555
Brand Name
TipStop
Version/Model Number
114555
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
KMF
Product Code Name
Bandage, liquid
Public Device Record Key
7ab4fcfe-e8a3-47af-b9de-69b7f7d8566c
Public Version Date
March 04, 2019
Public Version Number
1
DI Record Publish Date
February 01, 2019
Package DI Number
37332414113859
Quantity per Package
200
Contains DI Package
07332414113858
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |