Duns Number:078807493
Device Description: Medium-Duty Dual Yoke
Catalog Number
0682-400-600
Brand Name
NA
Version/Model Number
0682400600
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
FQO
Product Code Name
TABLE, OPERATING-ROOM, AC-POWERED
Public Device Record Key
1693cadb-8857-497a-998e-1a88873e9372
Public Version Date
August 06, 2020
Public Version Number
1
DI Record Publish Date
July 29, 2020
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 | 44 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |