FDA UDI
In Commercial Distribution
🇺🇸 United States
TRAPEZE ARM ASSEMBLY, PATIENT HELPER
DI: 00842430116728
·
Model: 3423-05
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TRAPEZE ARM ASSEMBLY, PATIENT HELPER
- Primary DI
- 00842430116728
- Version / Model
- 3423-05
- Catalog Number
- 3423-05
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-28
- Public Version
- 1
- Public Version Date
- 2025-08-05
- Public Version Status
- New
- Public Device Record Key
- d78e175c-a8ec-4069-a6a0-f9b021e11855
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 |
|---|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | Orthopedic | 888.5850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37510 | Assistive patient lifting pole | A device designed as an overhead bar with a hanging handgrip above the occupant of the bed that is attached to a medical bed or secured to the wall behind the bed and used by the occupant to provide support when changing position or pulling themselves into a sitting position. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430116728 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]