Duns Number:103021940
Device Description: TRAY RING COVER, STERILE
Catalog Number
OM271000
Brand Name
NA
Version/Model Number
OM271000
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
K951462,K951462
Product Code
HQC
Product Code Name
Unit, phacofragmentation
Public Device Record Key
8fad3012-31bd-41ec-8665-4369b9d42402
Public Version Date
February 26, 2020
Public Version Number
3
DI Record Publish Date
April 01, 2019
Package DI Number
15050474520704
Quantity per Package
48
Contains DI Package
05050474520707
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 | 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 |