Duns Number:044611812
Device Description: Groshong Catheter 4F Single-Lumen Basic Kit
Catalog Number
7715405
Brand Name
Groshong Catheter
Version/Model Number
7715405
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
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
9cdc356c-10fb-4320-a01a-b43a260228ed
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2015
Package DI Number
10801741035293
Quantity per Package
5
Contains DI Package
00801741035296
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 |