FDA UDI
In Commercial Distribution
🇺🇸 United States
Matrx Elite TR HD Back
DI: 07540147000103
·
Model: PBE-HDTR
·
Motion Concepts Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Matrx Elite TR HD Back
- Primary DI
- 07540147000103
- Version / Model
- PBE-HDTR
- Catalog Number
- PBEwwhh-HDTR
- Company Name
- Motion Concepts Inc
- Labeler DUNS
- 259777209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 5c5dfc00-4ab3-4950-8b6c-dd3fee0343a4
Device Description
Matrx Elite TR Heavy-Duty Back Support. (3" contour depth; 500lb. weight capacity). Matrx Elite TR backs are specially designed for use in manual or power tilt only or tilt/recline applications. It includes an extra layer of SuperSoft foam for improved immersion and comfort, and full support across the shoulder area
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
- No
- 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 |
|---|---|---|---|---|
| IMP | Cushion, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36254 | Wheelchair back rest | A padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540147000103 | GS1 |
Customer Contacts
- Phone
- 1-888-433-6818
- [email protected]