Duns Number:940023385
Device Description: Arterial, 1-part, 19 ga x 2 3/4"
Catalog Number
-
Brand Name
Inrad
Version/Model Number
57019
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
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
6485a9a8-a6c7-470f-9ec1-d9e9c6f0a1c4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 01, 2016
Package DI Number
10817295020548
Quantity per Package
20
Contains DI Package
00817295020541
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |