Duns Number:069862878
Device Description: Extension arm for use with the VYCOR Brain Access System (VBAS)
Catalog Number
VY1021-01
Brand Name
VBAS Extension Arm
Version/Model Number
VY1021-01
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
GDJ
Product Code Name
Clamp, Surgical, General & Plastic Surgery
Public Device Record Key
ce1b61a5-b030-41ca-aac1-6b08c940c60c
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
July 17, 2020
Package DI Number
00850003228082
Quantity per Package
1
Contains DI Package
00850003228075
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |