Duns Number:315731430
Device Description: CMOS Video-Rhino-Laryngoscope, 2.9 mm
Catalog Number
-
Brand Name
n.a.
Version/Model Number
11102CM
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
K182186
Product Code
EOB
Product Code Name
Nasopharyngoscope (flexible or rigid)
Public Device Record Key
247e2aa1-390a-4676-a558-e56adaac769f
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
January 11, 2020
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 | 3584 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4864 |
| 3 | A medical device with high risk that requires premarket approval | 18 |