Duns Number:711789789
Device Description: "MB-326 EYECUP F/OES FIBERSCOPE"
Catalog Number
-
Brand Name
OES EYEPIECE HOOD
Version/Model Number
MB-326
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 12, 2022
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
K910423
Product Code
EOQ
Product Code Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
d38529b3-02e3-468f-b2b3-deb68119b320
Public Version Date
August 15, 2022
Public Version Number
6
DI Record Publish Date
September 21, 2016
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 | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |