Duns Number:600235289
Device Description: Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways Colibri micro ENT scope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
Catalog Number
ERW-0100
Brand Name
Colibri micro ENT scope
Version/Model Number
ERW-0100
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"
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
K192305,K192305
Product Code
EOB
Product Code Name
Nasopharyngoscope (Flexible Or Rigid)
Public Device Record Key
0a788c81-22a8-444d-8e76-df856ae66f92
Public Version Date
May 29, 2020
Public Version Number
1
DI Record Publish Date
May 21, 2020
Package DI Number
07290016539110
Quantity per Package
10
Contains DI Package
07290016539103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |