FDA UDI
In Commercial Distribution
🇺🇸 United States
Assembly Required Distributors Inc.
DI: 00860004575641
·
Model: AC1507-01
·
Assembly Required Distributors Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Assembly Required Distributors Inc.
- Primary DI
- 00860004575641
- Version / Model
- AC1507-01
- Company Name
- Assembly Required Distributors Inc
- Labeler DUNS
- 170562396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 2
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- dfa72199-ccc8-4290-8971-850e62fb8e37
Device Description
Rear Anti-Tippers, MRI style with rubber tips, 4 holes and double push button pin
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 |
|---|---|---|---|---|
| IMR | Device, Anti-Tip, Wheelchair | Physical Medicine | 890.3920 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860004575641 | GS1 |