Duns Number:062046149
Device Description: Patient cable cleared with S4 transmitter
Catalog Number
-
Brand Name
Surveyor Patient Cable
Version/Model Number
9293-059-53
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
K141020,K160685
Product Code
DRG
Product Code Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Public Device Record Key
e7f42691-5d19-4b01-a089-bd4b25005802
Public Version Date
June 29, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
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. | 760 |