FDA UDI
In Commercial Distribution
🇺🇸 United States
Protekt Parts
DI: 05060488572944
·
Model: PP-RATK3
·
PROACTIVE MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Protekt Parts
- Primary DI
- 05060488572944
- Version / Model
- PP-RATK3
- Catalog Number
- PP-RATK3
- Company Name
- PROACTIVE MEDICAL PRODUCTS, LLC
- Labeler DUNS
- 078582655
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-18
- Public Version
- 1
- Public Version Date
- 2022-11-28
- Public Version Status
- New
- Public Device Record Key
- abcec6b4-bfa5-412a-886a-e27b636fa6c3
Device Description
K3 Anti-Tipper w/ Wheels (STDS819)
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
- Yes
- 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 |
|---|---|---|---|---|
| IML | ARMREST, 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 | 05060488572944 | GS1 |
Customer Contacts
- Phone
- +1 (855) 237 7622
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 4 | Inch | |
| Length | 8 | Inch | |
| Width | 2 | Inch |