FDA UDI
In Commercial Distribution
🇺🇸 United States
LOSPA IS Spinal Fixation System
DI: 08800017277707
·
Model: SI.AP6.0031
·
Corentec Co., Ltd
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LOSPA IS Spinal Fixation System
- Primary DI
- 08800017277707
- Version / Model
- SI.AP6.0031
- Company Name
- Corentec Co., Ltd
- Labeler DUNS
- 688739895
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-25
- Public Version
- 3
- Public Version Date
- 2024-07-22
- Public Version Status
- Update
- Public Device Record Key
- 560147d7-1e8b-456f-ad3a-9ef75f55c70b
Device Description
Spinal Instrument - ROD ROCKER FORCEPS TYPE
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
- No
- 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 |
|---|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64479 | Surgical implant handling forceps | A hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. It is made of metal materials and may have one of various designs (e.g., tweezers-, scissors-, alligator-like) whereby the blades are designed to be opened/closed to handle a variety of implantable devices (e.g., orthopaedic joint prosthesis, breast implant, surgical mesh). This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800017277707 | GS1 |
Customer Contacts
- Phone
- +82269374902
- [email protected]