Duns Number:021056726
Device Description: 23ga VersaVIT 2.0™ Procedure Pack with Mid-Field Illuminator
Catalog Number
70023S
Brand Name
Synergetics
Version/Model Number
70023S
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
Yes
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
HQE
Product Code Name
INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
Public Device Record Key
579d4e2f-c35e-4bea-a2d7-4ea7eba63f45
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
July 22, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 336 |
2 | A medical device with a moderate to high risk that requires special controls. | 47 |