Duns Number:058614483
Device Description: Quatro Starter Kit, (1) 186-0106, (5) 186-0150-PH
Catalog Number
186-0150-PH
Brand Name
BIS
Version/Model Number
186-0150-PH
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K093183,K093183,K093183
Product Code
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
9c314f8a-032a-43fc-8878-28ec713349b7
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
June 20, 2018
Package DI Number
90884521211267
Quantity per Package
9999
Contains DI Package
10884521657823
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |