Duns Number:114773653
Device Description: CathGrip Oval, Small, Non-Sterile, Latin America
Catalog Number
-
Brand Name
CathGrip
Version/Model Number
54002NSLA
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
9abd5123-f6ce-4aaf-83e3-6fb32fa9e13d
Public Version Date
September 21, 2021
Public Version Number
1
DI Record Publish Date
September 13, 2021
Package DI Number
10653599001544
Quantity per Package
30
Contains DI Package
00653599001547
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 |