Duns Number:160020087
Device Description: Pegasus Wireless Endoscopy System - Single Use Arthroscope
Catalog Number
-
Brand Name
Pegasus
Version/Model Number
1000
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"
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
K191345
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
4380a7b7-3968-4d4f-8c70-052796cb92e2
Public Version Date
August 08, 2019
Public Version Number
1
DI Record Publish Date
July 31, 2019
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |