Identity
- Trade Name
- AVAflex FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- AVAFLEX™ VERTEBRAL AUGMENTATION NEEDLE 10G FDA UDI
- Model / Reference
- AFH0010 FDA UDI
- Description
- AVAFLEX™ VERTEBRAL AUGMENTATION NEEDLE 10G FDA UDI
Identifiers
- Catalog Number
- AFH0010 FDA UDI
- Primary DI / UDI-DI
- 10885403219788 FDA UDI
- FDA Product Code
- OAR FDA UDI
- GMDN Term
- Balloon kyphoplasty kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Needle Gauge — 10 Gauge FDA UDI
AVAflex by Carefusion 2200, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Carefusion 2200, Inc.
Sources (1)
- FDA UDI 3dfd8821-a571-4ba0-8a7e-06278c0d2df1 36 fields · synced Sep 18, 2026