Duns Number:063519193
Device Description: Preferred Surgical Products C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC Min Preferred Surgical Products C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC Mini 6800/6600 20 per Case
Catalog Number
-
Brand Name
Perferred Surgical Products
Version/Model Number
28695
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
710263d0-5c3a-4b33-b4be-7b16430cf685
Public Version Date
March 13, 2020
Public Version Number
3
DI Record Publish Date
October 13, 2016
Package DI Number
00618125175482
Quantity per Package
20
Contains DI Package
01618125175481
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |