FDA UDI
In Commercial Distribution
🇺🇸 United States
Staxi
DI: 00850039103605
·
Model: MR1550
·
Staxi Corporation
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Staxi
- Primary DI
- 00850039103605
- Version / Model
- MR1550
- Company Name
- Staxi Corporation
- Labeler DUNS
- 078405541
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-11
- Public Version
- 1
- Public Version Date
- 2026-02-19
- Public Version Status
- New
- Public Device Record Key
- fc91c837-8788-46eb-87c1-2d7ba43ef89e
Device Description
The MR Chair Tip Restrictors are stability accessories intended to further limit the degree of rearward tipping of a Staxi MR Chair during use within MR environments, supplementing the chair’s integrated tip-restricting features. The Tip Restrictors are MRI Conditional and are intended for use only under the specific MRI conditions provided in the product labeling and instructions for use.
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 32987 | Wheelchair antitip device | A device that is added to the front or rear of a wheelchair to prevent upset by limiting the degree of forward or backward tilting that can occur. The device, typically made of metal, may appear as a rod-like arm with or without a wheel at its distal end, and is mounted to the wheelchair in pairs. The device should have sufficient strength to function as intended when the wheelchair is carrying its maximum load on the steepest intended slope. | No | Active |
| 43031 | Wheelchair medical gas supply/intravenous pole holder | A device typically constructed of metal and intended to be attached to a wheelchair to mount a medical gas supply (e.g., an oxygen cylinder) and/or an intravenous (IV) pole. It is typically used during patient transport. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850039103605 | GS1 |