FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 10885380086137
·
Model: CH10-0032
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 10885380086137
- Version / Model
- CH10-0032
- Catalog Number
- CH10-0032
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-05
- Public Version
- 2
- Public Version Date
- 2018-07-23
- Public Version Status
- Update
- Public Device Record Key
- 1c1bd868-030e-43b0-83f4-c86488f986d3
- Distribution End Date
- 2018-06-05
Device Description
Push-Pull Reduction Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47904 | Orthopaedic bone-reduction tool | A hand-held manual surgical instrument that is fed down the intramedullary canal of a long bone (e.g., the femur) to help reposition a fracture where the two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. It is typically a short cylindrical device with a protruding pointed tip (straight or angled) and which is secured to the distal end of a long, thin, flexible rod/shaft having a handle at the proximal end. It is pressed down the intramedullary canal to the fracture site and the surgeon manipulates the alignment, reducing the bone fragments under image-intensifier control. It is made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885380086137 | GS1 |