Duns Number:938647021
Device Description: Swivel Connector
Catalog Number
-
Brand Name
None
Version/Model Number
490108
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
9f9c1c6c-ea81-4a2c-bb8d-9abdc99d80cd
Public Version Date
September 09, 2020
Public Version Number
5
DI Record Publish Date
March 21, 2019
Package DI Number
10886874116200
Quantity per Package
5
Contains DI Package
00886874116203
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 |