Duns Number:103021940
Device Description: ONE SERIES ULTRA CARTRIDGE 30/BOX
Catalog Number
1VIPR30
Brand Name
ONE SERIES ULTRA
Version/Model Number
1VIPR30
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
K081545,K081545
Product Code
KYB
Product Code Name
LENS, GUIDE, INTRAOCULAR
Public Device Record Key
ecf75317-5a3a-43fb-8c5a-261b3fd1eac3
Public Version Date
February 26, 2020
Public Version Number
2
DI Record Publish Date
February 13, 2019
Package DI Number
15050474534602
Quantity per Package
30
Contains DI Package
05050474534605
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 3950 |