Duns Number:080375891
Device Description: Intraocular injection kit - standard set with drape (speculum, marker, drape, 18ga needle, Intraocular injection kit - standard set with drape (speculum, marker, drape, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe)
Catalog Number
VS0520
Brand Name
I² Kit for intraocular injection
Version/Model Number
VS0520
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
90f27c0b-8a7e-4a5d-8af8-d9adb8d1b31f
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
December 07, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |