Duns Number:611655440
Device Description: Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validat Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling
Catalog Number
-
Brand Name
pioli™ IOL Delivery System
Version/Model Number
PIOLI-D
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172228,K172228
Product Code
MSS
Product Code Name
Folders And Injectors, Intraocular Lens (Iol)
Public Device Record Key
937f382f-bd51-42fb-b580-4f2e444c77af
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 14, 2018
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 | 4 |