Duns Number:015409582
Device Description: 1 Each 54416 HD LenZ for ZEISS RESIGHT®, 1 Each 40417 Hassan-Tornambe Contact Lens, & 1 Ea 1 Each 54416 HD LenZ for ZEISS RESIGHT®, 1 Each 40417 Hassan-Tornambe Contact Lens, & 1 Each 51555 ZEISS RESIGHT® Microscope Head Cover Drape
Catalog Number
54019
Brand Name
HD LenZ Pack Plus, for ZEISS RESIGHT®
Version/Model Number
54019
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"
Yes
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
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
6f57e85c-10f2-44ad-a51a-fccc54445357
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
November 24, 2020
Package DI Number
00856222004735
Quantity per Package
8
Contains DI Package
00856222004728
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |