Duns Number:243821688
Device Description: iCE Series - Dual Mount Reverse Dual Arm (1000mm-1000mm, 1200mm-1200mm)
Catalog Number
LP-L-1122-R-E
Brand Name
iCE boom and Pendant
Version/Model Number
iCE - Spectra LP
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
FQO
Product Code Name
Table, Operating-Room, Ac-Powered
Public Device Record Key
e00c2f15-26e4-4f4f-9eb9-731aa715e442
Public Version Date
December 24, 2021
Public Version Number
1
DI Record Publish Date
December 16, 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 | 102 |
2 | A medical device with a moderate to high risk that requires special controls. | 405 |