Duns Number:161770292
Device Description: NON-STERILE DISPOSABLE EQUIPMENT COVER KIT - MONITOR COVER 22" X 15", KEYBOARD COVER 10" X NON-STERILE DISPOSABLE EQUIPMENT COVER KIT - MONITOR COVER 22" X 15", KEYBOARD COVER 10" X 20", MOUSE COVER 5" X 5"
Catalog Number
PC-01-K
Brand Name
PREFERRED MEDICAL PRODUCTS, LLC
Version/Model Number
PC-01-K
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K863853,K863853,K863853,K863853
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
ef50671b-869b-421b-95e2-107701837ecb
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
May 12, 2020
Package DI Number
40680211010005
Quantity per Package
10
Contains DI Package
00680211010007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |