Duns Number:044611812
Device Description: Groshong 9.5F Dual-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrow Groshong 9.5F Dual-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Intermediate Kit (Dual-Lumen)
Catalog Number
6626954
Brand Name
Groshong 9.5 F Dual-Lumen CV Catheter
Version/Model Number
6626954
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
1fff9a64-c4b7-4642-937a-97c705d592a3
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
10801741041560
Quantity per Package
5
Contains DI Package
00801741041563
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |