Duns Number:005036025
Device Description: The Midmark 204 Manual Examination Table is intended to be used as a table to provide posi The Midmark 204 Manual Examination Table is intended to be used as a table to provide positioning and support of patients during examination procedures conducted by qualified medical professionals in an office environment.
Catalog Number
204-013
Brand Name
Midmark
Version/Model Number
204 Manual Examination Table
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"
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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
FRK
Product Code Name
CHAIR, EXAMINATION AND TREATMENT
Public Device Record Key
563e2ec2-fbe9-4100-8d30-f7d4a785d370
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 15, 2018
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 |