Duns Number:006261481
Device Description: PROBE CB2980POLY FLOW BIOACTIVE 10PK
Catalog Number
-
Brand Name
Bio-Probe®
Version/Model Number
CB2980POLY
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2018
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
K830858,K830858
Product Code
DPT
Product Code Name
PROBE, BLOOD-FLOW, EXTRAVASCULAR
Public Device Record Key
7b7d4dee-096c-4a92-8e25-41c67ed50d1c
Public Version Date
March 08, 2019
Public Version Number
4
DI Record Publish Date
July 08, 2016
Package DI Number
20721902987780
Quantity per Package
10
Contains DI Package
00721902987786
Package Discontinue Date
October 05, 2018
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |