Duns Number:058614483
Device Description: Acute Dual Lumen Catheter Tray Pre-Curved with IC Components
Catalog Number
-
Brand Name
MAHURKAR
Version/Model Number
8888115193
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 29, 2020
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
Yes
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
8e88af9f-c38c-4f39-9fe6-568aa0d61e0f
Public Version Date
May 06, 2022
Public Version Number
8
DI Record Publish Date
October 22, 2015
Package DI Number
20884521005447
Quantity per Package
5
Contains DI Package
10884521005440
Package Discontinue Date
April 29, 2020
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |