Duns Number:114773653
Device Description: CathGrip Oval, Medium, Sterile
Catalog Number
-
Brand Name
CathGrip
Version/Model Number
53002
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)
-
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
47d94f2f-c51e-4a20-80f5-ebc4d2d18469
Public Version Date
January 15, 2020
Public Version Number
1
DI Record Publish Date
January 07, 2020
Package DI Number
10653599000684
Quantity per Package
30
Contains DI Package
00653599000687
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 | 84 |