Duns Number:078375583
Device Description: 3/8 Inch SEAT SECTION 3500 SERIAL No 1996-067 AND LATER
Catalog Number
5-010-16-3B
Brand Name
Skytron
Version/Model Number
5-010-16-3B
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQO
Product Code Name
TABLE, OPERATING-ROOM, AC-POWERED
Public Device Record Key
8112c9d6-16e5-4a7b-9d82-c9cb9318d308
Public Version Date
February 07, 2022
Public Version Number
1
DI Record Publish Date
January 29, 2022
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 | 747 |
2 | A medical device with a moderate to high risk that requires special controls. | 265 |