FDA UDI
In Commercial Distribution
🇺🇸 United States
FEMUR LIFT ACESSORIES KIT, JP RAIL
DI: 00842430116285
·
Model: 6879-2-1
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FEMUR LIFT ACESSORIES KIT, JP RAIL
- Primary DI
- 00842430116285
- Version / Model
- 6879-2-1
- Catalog Number
- 6879-2-1
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-19
- Public Version
- 1
- Public Version Date
- 2023-09-27
- Public Version Status
- New
- Public Device Record Key
- 9c0f9645-b861-47cc-baa0-b4408350d16f
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 |
|---|---|---|---|---|
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62665 | Femur lifter, manual | A manually-operated, multi-jointed, mechanical device intended to support and elevate a patient¿s femur for optimal positioning during hip replacement surgery. It is designed to be fixed to an operating table and includes a vertical lifting post, a handcrank for height adjustment, mounting clamps/adaptors, and leg support components. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430116285 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]