Identity
- Trade Name
- Osseoflex® FDA UDI
- Generic Name
- Vertebral body cement cannula FDA UDI
- Model / Reference
- 00884450327951 FDA UDI
Identifiers
- Catalog Number
- OF-0298/A FDA UDI
- Primary DI / UDI-DI
- 00884450327951 FDA UDI
- FDA Product Code
- OAR FDA UDI
- GMDN Term
- Vertebral body cement cannula FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vertebral body cement cannula
Osseoflex is a sterile, manual, tubular device designed to create a percutaneous access channel into a vertebral body prior to and during injection of orthopaedic cement into the vertebral body during kyphoplasty.
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Also classified as Vertebral body cement cannula.
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- VertePort — Stryker Corp. · Class I
- Keyfix direct access needle 8G — G21 SRL · Class I
- VertePort — Stryker Corp. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 855e819f-d93f-464f-8cac-f3331dcc64ca 34 fields · synced Jul 14, 2026