Duns Number:340146982
Device Description: M3D two-tube wheelchair mount with curved tube. RotLok base with swivel function and UDS-D M3D two-tube wheelchair mount with curved tube. RotLok base with swivel function and UDS-DC. Dimensions (height x offset x tube 2): 860 x 300 x 400 mm (34 x 12 x 16"). Max. load capacity: 3.0 kg (6.6 lbs). Frame clamp not included.
Catalog Number
-
Brand Name
Monty 3D Curved XL
Version/Model Number
11.7312
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
KNO
Product Code Name
Accessories, Wheelchair
Public Device Record Key
000746b6-f11c-4e27-91f2-e38a6c8e4d1a
Public Version Date
August 03, 2022
Public Version Number
1
DI Record Publish Date
July 26, 2022
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 | 10 |