Duns Number:030650113
Device Description: Ultima Cable for HRCA Manometry Probe (Lemo Connector)
Catalog Number
H12R-7210
Brand Name
Ultima
Version/Model Number
H12R-7210
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
-
Product Code
FFX
Product Code Name
System, Gastrointestinal Motility (Electrical)
Public Device Record Key
245686cb-fcb5-4d8f-b03f-3951ab80d045
Public Version Date
March 09, 2021
Public Version Number
1
DI Record Publish Date
March 01, 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 | 109 |
2 | A medical device with a moderate to high risk that requires special controls. | 207 |