Identity
- Trade Name
- AVAflex FDA UDI
- Generic Name
- Orthopaedic cement injection cannula FDA UDI
- Device Name
- AVAflex Curved Needle Kit FDA UDI
- Model / Reference
- 1025011000 FDA UDI
- Description
- AVAflex Curved Needle Kit FDA UDI
Identifiers
- Catalog Number
- 1025-011-000 FDA UDI
- Primary DI / UDI-DI
- 07613327374612 FDA UDI
- FDA Product Code
- OAR FDA UDI
- GMDN Term
- Orthopaedic cement injection 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
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 — 11.0 Gauge FDA UDI
Category: Orthopaedic cement injection cannula
AVAflex by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement injection cannula.
- Revision Cannula — Tecres · Class I
- IM Nail Dispenser Mold — BONESETTER HOLDINGS, LLC · Class I
- PERLA® TL MIS — Spineart · Class II
- Graft Delivery System — Nuvasive, Inc. · Class I
- Hip Instruments — Medacta International · Class I
- SmartMix™ Narrow Straight Nozzle — Summit Medical, LLC · Class I
- Flow-Screw™ — Flow-Fx, LLC · Class I
- IM Nail Dispenser Mold — BONESETTER HOLDINGS, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 38cad0c4-73d6-4d35-913e-6ee411d1546d 37 fields · synced May 30, 2026