Duns Number:084527241
Catalog Number
6977-4006RF
Brand Name
KIT, FRU, CNTL BOX W/MNTS 120V REFURB
Version/Model Number
6977-4006RF
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JEA
Product Code Name
Table, Surgical With Orthopedic Accessories, Ac-Powered
Public Device Record Key
6a17a7a4-42af-4407-971f-409c13e6c6d9
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
January 05, 2021
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 | 1076 |
2 | A medical device with a moderate to high risk that requires special controls. | 44 |