Duns Number:040748944
Device Description: Basic ENT Field. This kit contains a versatile set of components designed to facilitate e Basic ENT Field. This kit contains a versatile set of components designed to facilitate effective examination of the eyes, ears, nose and throat.
Catalog Number
ENT-BFK
Brand Name
CFM Technologies
Version/Model Number
ENT-BFK
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ERA
Product Code Name
Otoscope
Public Device Record Key
31909f2f-ab28-45fd-8d74-66cd6f9c039a
Public Version Date
May 10, 2021
Public Version Number
3
DI Record Publish Date
January 06, 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 | 26 |