Duns Number:058614483
Device Description: Alcohol Free Anti-Fog Kit
Catalog Number
-
Brand Name
Fred Lite
Version/Model Number
220-70
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2022
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
K923843,K923843
Product Code
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
aa3bbea2-659e-4fde-9fe0-a3ad77b6be8c
Public Version Date
September 14, 2022
Public Version Number
7
DI Record Publish Date
September 29, 2016
Package DI Number
10884521066557
Quantity per Package
20
Contains DI Package
20884521066554
Package Discontinue Date
April 22, 2022
Package Status
Not 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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |