Duns Number:827608774
Device Description: BiMobile Trial D58
Catalog Number
-
Brand Name
LinkBio Instrument
Version/Model Number
87-6051/58
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
HWT
Product Code Name
Template
Public Device Record Key
ea76e08d-a217-48d1-8d51-889fe32048f9
Public Version Date
July 04, 2022
Public Version Number
1
DI Record Publish Date
June 24, 2022
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 | 92 |