Duns Number:604056226
Device Description: 2 Light Handle Cover; green, disposable; pouch
Catalog Number
-
Brand Name
Key Surgical Light Handle Cover
Version/Model Number
LHC-302-080
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 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"
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
FTA
Product Code Name
Light, Surgical, Accessories
Public Device Record Key
9cae9117-c1f9-4531-aa51-c01bd8bbd195
Public Version Date
February 25, 2022
Public Version Number
11
DI Record Publish Date
August 23, 2016
Package DI Number
10849771030611
Quantity per Package
80
Contains DI Package
00849771030614
Package Discontinue Date
December 03, 2021
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 | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |