FDA UDI
In Commercial Distribution
🇺🇸 United States
Songer® Spinal Cable System
DI: 00840298704620
·
Model: 400-120
·
Pioneer Surgical Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Songer® Spinal Cable System
- Primary DI
- 00840298704620
- Version / Model
- 400-120
- Catalog Number
- 7825-111
- Company Name
- Pioneer Surgical Technology, Inc.
- Labeler DUNS
- 793384496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-23
- Public Version
- 3
- Public Version Date
- 2025-12-16
- Public Version Status
- Update
- Public Device Record Key
- 278a18da-1902-4f48-bacb-cd9473527edf
Device Description
Crimper/Tensioner
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
- Yes
- 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 |
|---|---|---|---|---|
| HWN | INSTRUMENT, COMPRESSION | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44801 | Internal spinal fixation system cable tensioner | A manual, hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a cable that is being implanted as part of a system to provide corrective surgery for the spine. The device is typically made of high-grade stainless steel, and is designed with a low intrusion profile to minimize the surgical exposure required for tightening the cables in situ. It will also be equipped with a means for accurate and reproducible tensioning of the cable(s). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840298704620 | GS1 | ||||
| Previous | 10846468005389 | GS1 |
Customer Contacts
- Phone
- +1(906)226-9909
- [email protected]