Duns Number:080935394
Device Description: Field generator clamp assembly that connects the Planar Field generator to the hospital be Field generator clamp assembly that connects the Planar Field generator to the hospital bed
Catalog Number
-
Brand Name
Acessa ProVu PFG Table Clamp
Version/Model Number
MS-05-0257
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"
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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
HFG
Product Code Name
Coagulator, Laparoscopic, Unipolar (And Accessories)
Public Device Record Key
65cf0fb2-6206-4027-95f3-40c444c29863
Public Version Date
August 10, 2020
Public Version Number
2
DI Record Publish Date
October 11, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |