FDA UDI
In Commercial Distribution
🇺🇸 United States
Assembly Required Distributors
DI: 00854362008156
·
Model: LR3207L-01
·
Assembly Required Distributors Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Assembly Required Distributors
- Primary DI
- 00854362008156
- Version / Model
- LR3207L-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
- 2018-03-21
- Public Version
- 3
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 14495e56-5be6-439c-99eb-4f939e0bd8f4
Device Description
L/R - Left Side - no calfpad -for24'HD & for 26' W/C seat width
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 |
|---|---|---|---|---|
| 32982 | Wheelchair footrest/legrest | A platform (typically metal with or without a padded vinyl covering) usually mounted on a wheelchair in pairs, and upon which a wheelchair occupant may place the feet/legs for comfort, support, and/or to keep them off of the ground. It typically includes a mounting frame, footrest, and may include a mounted pad(s) to support the calves of the legs; it may be fixed or adjustable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854362008156 | GS1 |