Duns Number:079375431
Device Description: CLEAR-SITE* Alcohol-Free Anti-Fog Kit
Catalog Number
50110
Brand Name
Halyard
Version/Model Number
50110
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 2018
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
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
78615767-022f-41f8-b9df-4b1a68993c76
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
June 05, 2017
Package DI Number
30680651501104
Quantity per Package
20
Contains DI Package
20680651501107
Package Discontinue Date
November 02, 2018
Package Status
Not in Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |