Identity
- Trade Name
- DragonWing FDA UDI
- Generic Name
- Bone grafting cannula FDA UDI
- Device Name
- Avitus DragonWing Large Volume Autograft Delivery (Ø5.2mm, 120mm system) FDA UDI
- Model / Reference
- AD-5ch-5.2-120 FDA UDI
- Description
- Avitus DragonWing Large Volume Autograft Delivery (Ø5.2mm, 120mm system) FDA UDI
Identifiers
- Catalog Number
- AD-5ch-5.2-120 FDA UDI
- Primary DI / UDI-DI
- 00857373006128 FDA UDI
- 510(k) Number
- K231456 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Bone grafting cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone grafting cannula
DragonWing by Avitus Orthopaedics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- One-Shot — Shanghai Kinetic Medical Co., Ltd. · Class I
- Vital™ — BIOMET SPINE 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 II | Pending data |
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Manufacturer
- Manufacturer
- Avitus Orthopaedics, Inc
Sources (1)
- FDA UDI ea1a2a1f-218e-4936-91be-fbfcb2d26012 36 fields · synced May 30, 2026