Duns Number:109903521
Device Description: BLACK FOCUS RING, 19.5 MM FOCAL LENGTH, 4.0 MM OUTER DI BLACK FOCUS RING, 19.5 MM FOCAL LENGTH, 4.0 MM OUTER DIAMETER, 70 DEGREE DIRECTION OF VIEW, 115 DEGREE FIELD OF VIEW, 160 MM WORKING LENGTH, SAME SIDE, J-LOCK, NON-AUTOCLAVABLE
Catalog Number
72202964
Brand Name
NA
Version/Model Number
72202964
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
K043395
Product Code
EOB
Product Code Name
NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
3b9f9c5c-43f9-4b80-b165-dcec63cdf0b3
Public Version Date
October 07, 2020
Public Version Number
5
DI Record Publish Date
August 29, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |