Duns Number:063519193
Device Description: Universal Securement Device, For lines and Tubes sized 3-8mm in diameter
Catalog Number
3300M-10PK
Brand Name
Grip-Lok
Version/Model Number
3300M-10PK
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
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
KMK
Product Code Name
Device, Intravascular Catheter Securement
Public Device Record Key
8846c53c-3fd1-46d6-8d6b-cc5ce87b8a16
Public Version Date
October 20, 2022
Public Version Number
1
DI Record Publish Date
October 12, 2022
Package DI Number
20618125134711
Quantity per Package
50
Contains DI Package
10618125134714
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |