Duns Number:243821688
Device Description: Spectra V Electric Series - 800-950 90KG 220V AUS
Catalog Number
LP-V-81-90-220A
Brand Name
iCE boom and Pendant
Version/Model Number
iCE - V-Series
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
7a81e45f-6956-4f5e-aacf-d135b3b8fd9a
Public Version Date
July 10, 2020
Public Version Number
1
DI Record Publish Date
July 02, 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 | 102 |
2 | A medical device with a moderate to high risk that requires special controls. | 405 |