Duns Number:005036025
Device Description: The Articulating Knee Crutch kit, with accessory receiver, (for the 625 Barrier-Free Exami The Articulating Knee Crutch kit, with accessory receiver, (for the 625 Barrier-Free Examination Table) is designed to be a more ergonomic and comfortable option compared to standard stirrups. The unique ball-socket design allows for a maximum range of adjustment, designed to ensure optimum knee and leg support.
Catalog Number
9A411006
Brand Name
Midmark
Version/Model Number
9A411006
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
0202c71b-7eb2-4ad3-8e86-10b41ea799dd
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 |