FDA UDI
In Commercial Distribution
🇺🇸 United States
Monty 3D Curved M
DI: B8961153110
·
Model: 11.5311
·
REHAdapt Engineering GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Monty 3D Curved M
- Primary DI
- B8961153110
- Version / Model
- 11.5311
- Company Name
- REHAdapt Engineering GmbH & Co. KG
- Labeler DUNS
- 340146982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-26
- Public Version
- 2
- Public Version Date
- 2024-07-25
- Public Version Status
- Update
- Public Device Record Key
- d93a485a-453b-4906-bb39-ff652cf8c5a7
Device Description
M3D two-tube wheelchair mount with curved tube. RotLok base with swivel function. Dimensions (height x offset x tube 2): 660 x 230 x 400 mm (26 x 9 x 16"). Max. load capacity: 3.0 kg (6.6 lbs). Frame clamp not included.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNO | Accessories, Wheelchair | Physical Medicine | 890.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61434 | Portable active medical device mount | A device intended to be fixed (e.g., to a healthcare facility wall, ambulance, trolley, floor) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B8961153110 | HIBCC |