Duns Number:005036025
Device Description: The Midmark UltraComfort Concept LR Dental Chair with Internal Umbilical (4ft.) and LR Uni The Midmark UltraComfort Concept LR Dental Chair with Internal Umbilical (4ft.) and LR Unit Mount is intended to provide patient support and positioning during dental exams.
Catalog Number
153562-006
Brand Name
Midmark
Version/Model Number
153592-006
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"
-
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
NRU
Product Code Name
CHAIR, DENTAL, WITHOUT OPERATIVE UNIT
Public Device Record Key
7519992b-a008-4482-a380-19d5614b1927
Public Version Date
November 09, 2020
Public Version Number
1
DI Record Publish Date
October 30, 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 | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |