Duns Number:239403863
Device Description: The camera sleeve is used to create a sterile field around the video system camera head an The camera sleeve is used to create a sterile field around the video system camera head and cable.
Catalog Number
PS3901
Brand Name
Camera sleeve
Version/Model Number
PS3901
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
-
Product Code
KQM
Product Code Name
Camera, Surgical And Accessories
Public Device Record Key
765920e5-4993-45b2-830f-959c21fca7f8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 16, 2017
Package DI Number
35051223029206
Quantity per Package
20
Contains DI Package
15051223029202
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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |