Duns Number:315304071
Device Description: LARYN-PHARYNGOSCOPE 90° Ø 10MM WL 161MM rigid, 2 zoom zone, TL 237mm, rod lens system, ma LARYN-PHARYNGOSCOPE 90° Ø 10MM WL 161MM rigid, 2 zoom zone, TL 237mm, rod lens system, manual focus, reusable
Catalog Number
885090
Brand Name
PANOVIEW PLUS
Version/Model Number
885090
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCW
Product Code Name
LARYNGOSCOPE, RIGID
Public Device Record Key
e074beb1-bf20-40e9-8bdf-8570d5954356
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 2022
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |