Duns Number:867673159
Device Description: Patient Room Overbed Tables Product Description OBT-Economy-SO-U-Opal-Van-Spcl
Catalog Number
-
Brand Name
AMFAB
Version/Model Number
16012-UOSOV
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
-
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
-
Product Code
INW
Product Code Name
TABLE, MECHANICAL
Public Device Record Key
750aa8df-cfc6-4be8-91f8-159d6dea6042
Public Version Date
February 10, 2020
Public Version Number
1
DI Record Publish Date
February 01, 2020
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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |