Duns Number:135057938
Device Description: BARD® PARSONNET™ Vascular Probe 3.5 mm x 45 cm
Catalog Number
007608
Brand Name
BARD® PARSONNET
Version/Model Number
007608
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
DWP
Product Code Name
DILATOR, VESSEL, SURGICAL
Public Device Record Key
9682ccc3-f2e7-47e0-826c-4ce64a63694d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
10801741090025
Quantity per Package
5
Contains DI Package
00801741090028
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |