Duns Number:264205501
Device Description: This machine controls the introduction of liquid into an articulation during arthroscopic This machine controls the introduction of liquid into an articulation during arthroscopic surgery. It can be used for diagnostic purposes as well as arthroscopic surgery and enables intra-articular distension to be maintained and rinsing to be carried out.
Catalog Number
S_670_0002
Brand Name
COMEG MEDICAL
Version/Model Number
S670 - IRRIGATEUR - SOPRO - US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
K080122
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
294c0014-b435-464c-a9d5-a95ccc47298a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |