FDA UDI
In Commercial Distribution
🇺🇸 United States
Optima™ Spinal System
DI: 08800015951999
·
Model: SP0011
·
CG MedTech Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Optima™ Spinal System
- Primary DI
- 08800015951999
- Version / Model
- SP0011
- Company Name
- CG MedTech 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
- 5
- Public Version Date
- 2025-01-06
- Public Version Status
- Update
- Public Device Record Key
- 4151d5e1-102a-4bc6-b609-f7e1c470adf1
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 |
|---|---|---|---|---|
| HXO | PUSHER, SOCKET | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47554 | Orthopaedic counter-torque/rod-pushing instrument | A hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800015951999 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place.