Identity
- Trade Name
- Songer® Spinal Cable System FDA UDI
- Generic Name
- Internal spinal fixation system cable FDA UDI
- Device Name
- Instrument Case FDA UDI
- Model / Reference
- 00-INSTCASE FDA UDI
- Description
- Instrument Case FDA UDI
Identifiers
- Catalog Number
- 00-INSTCASE FDA UDI
- Primary DI / UDI-DI
- 00846468016005 FDA UDI
- FDA Product Code
- JDQ FDA UDI
- GMDN Term
- Internal spinal fixation system cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3010 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Songer® Spinal Cable System by Pioneer Surgical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI c122e596-786b-4d5d-8dd4-861c8b8a76f6 36 fields · synced Jun 8, 2026