Duns Number:487158263
Device Description: Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.
Catalog Number
LP604340
Brand Name
VISCOJECT 2.2 INJECTOR-SET
Version/Model Number
LP604340
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
K101134,K101134
Product Code
MSS
Product Code Name
Folders And Injectors, Intraocular Lens (Iol)
Public Device Record Key
073f4d99-ddb8-4d6c-9a9b-c27883d1dd7a
Public Version Date
October 29, 2020
Public Version Number
1
DI Record Publish Date
October 21, 2020
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 | 33 |