Duns Number:344267187
Device Description: CESSYS® Dorsal FHD Laminoscope (4.7 WCh), ocular
Catalog Number
-
Brand Name
CESSYS®
Version/Model Number
LS7347068O
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
-
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
K051827
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
4ddbaf68-bb6b-4818-971c-e8c478d8b4e2
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 08, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 293 |