Duns Number:938647021
Device Description: Vision Probe
Catalog Number
-
Brand Name
Ion
Version/Model Number
490106
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
-
Product Code
EOQ
Product Code Name
Bronchoscope (flexible or rigid)
Public Device Record Key
31df6c87-e411-43e1-b2e2-f3fec667e219
Public Version Date
March 02, 2020
Public Version Number
2
DI Record Publish Date
March 21, 2019
Package DI Number
10886874116125
Quantity per Package
2
Contains DI Package
00886874116128
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 376 |