Duns Number:042826131
Device Description: Procedural Table is designed for use in procedure and examination areas of hospitals, clin Procedural Table is designed for use in procedure and examination areas of hospitals, clinics and general healthcare facilities. Tables have positioning capability to adjust table height and the tilt, back and foot sections of the upholstered couch sections by use of a foot control and/or optional hand control. This Procedural Table is intended to be used for general procedures and examinations, by qualified medical professionals and is designed to position and support patients during examination and/or procedures.
Catalog Number
6210
Brand Name
ENOCHS Examining Room Furniture
Version/Model Number
6210
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LGX
Product Code Name
Table, Examination, Medical, Powered
Public Device Record Key
c9d9bbad-8198-4236-8c33-83f3fbc1196b
Public Version Date
July 23, 2020
Public Version Number
1
DI Record Publish Date
July 15, 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 | 23 |