Duns Number:114773653
Device Description: CathGrip Double Strap, Large, Non-Sterile, Latin America
Catalog Number
-
Brand Name
CathGrip
Version/Model Number
51300NSLA
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
0bcbf9cb-9137-4e4d-b159-7e13a6239d2f
Public Version Date
August 24, 2021
Public Version Number
1
DI Record Publish Date
August 16, 2021
Package DI Number
10653599001452
Quantity per Package
30
Contains DI Package
00653599001455
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 |