RoughRider
GUDID 00860009406001
manually propelled wheelchair
Roughrider America LLC
Push-rim manual wheelchair, non-bariatric| Primary Device ID | 00860009406001 |
| NIH Device Record Key | 0be8e254-7571-476b-a8db-1cfb24f79e1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RoughRider |
| Version Model Number | RoughRider |
| Company DUNS | 052942916 |
| Company Name | Roughrider America LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009406001 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103212
FDA Product Code
| IOR | Wheelchair, Mechanical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-27 |
| Device Publish Date | 2023-02-17 |
On-Brand Devices [RoughRider]
| 00860009406087 | manually propelled wheelchair |
| 00860009406070 | manually propelled wheelchair |
| 00860009406063 | manually propelled wheelchair |
| 00860009406056 | manually propelled wheelchair |
| 00860009406049 | manually propelled wheelchair |
| 00860009406032 | manually propelled wheelchair |
| 00860009406025 | manually propelled wheelchair |
| 00860009406018 | manually propelled wheelchair |
| 00860009406001 | manually propelled wheelchair |
| 00860003056677 | Manually Propelled Wheelchair |
| 00860003056660 | Manually Propelled Wheelchair |
| 00860003056653 | Manually Propelled Wheelchair |
| 00860003056646 | Manually Propelled Wheelchair |
| 00860003056639 | Manually Propelled Wheelchair |
| 00860003056622 | Manually Propelled Wheelchair |
| 00860003056615 | Manually Propelled Wheelchair |
| 00860003056608 | Manually Propelled Wheelchair |
Trademark Results [RoughRider]
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