Duns Number:008018525
Device Description: The Monarch® "A" Cartridge is a single-use polypropylene cartridge for posterior chamber I The Monarch® "A" Cartridge is a single-use polypropylene cartridge for posterior chamber IOL delivery
Catalog Number
-
Brand Name
MONARCH® II
Version/Model Number
8065977757
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
KYB
Product Code Name
LENS, GUIDE, INTRAOCULAR
Public Device Record Key
a42924db-e1ae-4fa8-9bf7-8ec1dc1fee32
Public Version Date
May 28, 2020
Public Version Number
1
DI Record Publish Date
May 20, 2020
Package DI Number
10380659777575
Quantity per Package
10
Contains DI Package
00380659777578
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |