Duns Number:078807493
Device Description: Surgical Table Pad, 3 Inch Seat and Back with Cutouts, D8XX
Catalog Number
OZ 7569075
Brand Name
OPERON
Version/Model Number
OZ 7569075
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 29, 2021
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
-
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
LWG
Product Code Name
SURGICAL TABLE CUSHION
Public Device Record Key
e234fc4c-de30-40c3-857e-005d518e2d18
Public Version Date
April 29, 2021
Public Version Number
4
DI Record Publish Date
January 24, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 44 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |