Duns Number:938647021
Device Description: Vision Probe Adapter and Suction Adapter
Catalog Number
-
Brand Name
None
Version/Model Number
490101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 26, 2020
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
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
-
Product Code
EOQ
Product Code Name
Bronchoscope (flexible or rigid)
Public Device Record Key
2d8b02ce-ab64-4bb7-8f82-300933b0158f
Public Version Date
August 26, 2020
Public Version Number
4
DI Record Publish Date
May 30, 2019
Package DI Number
10886874116118
Quantity per Package
10
Contains DI Package
00886874116111
Package Discontinue Date
August 26, 2020
Package Status
Not 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 |