ProVu Video Stylet Single Use Wrist Holder for 3.5" Monitor
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- ProVu Video Stylet Single Use Wrist Holder for 3.5" Monitor FDA UDI
- Generic Name
- Artificial airway stylet, single-use FDA UDI
- Device Name
- Video Display Accessories EUDAMED
- Model / Reference
- 038-990-100U EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788782865 EUDAMEDFDA UDI
- Basic UDI-DI
- 5055788700015503HB EUDAMED
- FDA Product Code
- BSR FDA UDI
- EMDN Code
- Z12021004 VIDEO LARYNGOSCOPES EUDAMED
- GMDN Term
- Artificial airway stylet, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5790 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Artificial airway stylet, single-use
ProVu Video Stylet Single Use Wrist Holder for 3.5" Monitor by Flexicare Medical Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (2)
- FDA UDI d1314b4e-2583-4e38-be55-d6ef93747438 32 fields · synced Jun 14, 2026
- EUDAMED cc5a3cca-e8e5-479e-90c4-83a5a4fa9195 61 fields · synced Jun 11, 2026