Duns Number:071595540
Device Description: ECOFLOW 10K/24K ARTHOSCOPY DAY USE PUMP INFLOW TUBING SET, QTY 4
Catalog Number
10K600
Brand Name
10K ECOFLOW
Version/Model Number
10K600
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"
Yes
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
HRX
Product Code Name
Arthroscope
Public Device Record Key
9c381290-bd94-4900-bf2f-23a5fea5fb90
Public Version Date
October 17, 2022
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
20845854041267
Quantity per Package
4
Contains DI Package
10845854041260
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |