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Paediatric Ventimyst Dual Heated Wire B/S 1.6m (63") Kit 2
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Paediatric Ventimyst Dual Heated Wire B/S 1.6m (63") Kit 2 FDA UDI
- Generic Name
- Carpal lunate prosthesis FDA UDI
- Model / Reference
- 038-32-252U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788770008 FDA UDI
- FDA Product Code
- BZE FDA UDIBTT FDA UDI
- GMDN Term
- Carpal lunate prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5270 FDA UDI868.5450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
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: Carpal lunate prosthesis
Paediatric Ventimyst Dual Heated Wire B/S 1.6m (63") Kit 2 by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Carpal lunate prosthesis.
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED · Class II
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED · Class II
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED · Class II
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc. · Class II
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED · Class II
- PyroCarbon Lunate — Smith & Nephew, Inc. · Class II
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED · Class II
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED · Class II
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
- Flexicare Medical Limited
Sources (1)
- FDA UDI 7eed3cb7-4c99-4145-b6e7-02c6ce707634 32 fields · synced May 31, 2026