FDA UDI
In Commercial Distribution
🇺🇸 United States
Global Spinal Fixation System™
DI: 08800015946339
·
Model: SG0003
·
Innosys Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Global Spinal Fixation System™
- Primary DI
- 08800015946339
- Version / Model
- SG0003
- Company Name
- Innosys Co., Ltd.
- Labeler DUNS
- 688811082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-02
- Public Version
- 4
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- 2ce7cc7d-631f-47db-b0f4-4ebd34c53a80
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
- Yes
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48025 | Orthopaedic bone-fragment manipulator, reusable | A hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800015946339 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place.