Identity
- Trade Name
- Sense Mirror FDA UDI
- Generic Name
- Urethral self-catheterization assistive mirror FDA UDI
- Device Name
- Urinary catheter positioning mirror FDA UDI
- Model / Reference
- 3895 FDA UDI
- Description
- Urinary catheter positioning mirror FDA UDI
Identifiers
- Catalog Number
- 3895 FDA UDI
- Primary DI / UDI-DI
- 07392532176494 FDA UDI
- FDA Product Code
- FTX FDA UDI
- GMDN Term
- Urethral self-catheterization assistive mirror FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 70 Millimeter FDA UDILength — 125 Millimeter FDA UDI
Sense Mirror by Wellspect AB — 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
- Wellspect AB
Sources (1)
- FDA UDI 1cf56f91-2cab-44ec-83d4-091ad90f55e2 38 fields · synced May 30, 2026