Duns Number:161770292
Device Description: STERILE DISPOSABLE EQUIPMENT COVER - PROBE COVER 4" X 96" - BANDS, TAPERED END, SCRUNCH FO STERILE DISPOSABLE EQUIPMENT COVER - PROBE COVER 4" X 96" - BANDS, TAPERED END, SCRUNCH FOL
Catalog Number
PC-0496 W/B
Brand Name
PREFERRED MEDICAL PRODUCTS, LLC
Version/Model Number
PC-0496 W/B
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"
Yes
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
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
05614594-f48e-4050-9f6e-79611ea5110c
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
July 01, 2019
Package DI Number
30680211002843
Quantity per Package
100
Contains DI Package
00680211002842
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 |