Duns Number:005036025
Device Description: The Adjustable Arm System (arms only) is designed to offer patients a stable platform in a The Adjustable Arm System (arms only) is designed to offer patients a stable platform in accessing the table and a sense of security during positioning. Arms rotate and lock into one of three positions and are easily removable.
Catalog Number
9A627001
Brand Name
Midmark
Version/Model Number
9A627001
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
FRK
Product Code Name
CHAIR, EXAMINATION AND TREATMENT
Public Device Record Key
0184c2ac-4fb2-4b52-a9e3-a8a96ffe9cdf
Public Version Date
March 02, 2020
Public Version Number
1
DI Record Publish Date
February 21, 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 |