Identity
- Trade Name
- Virtue FDA UDI
- Generic Name
- Male stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
- Device Name
- Male Sling System FDA UDI
- Model / Reference
- 50020 FDA UDI
- Description
- Male Sling System FDA UDI
Identifiers
- Catalog Number
- 50020 FDA UDI
- Primary DI / UDI-DI
- 05708932499149 FDA UDI
- FDA Product Code
- OTM FDA UDI
- GMDN Term
- Male stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
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
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: Suturing unit, single-useMale stress urinary incontinence surgical mesh-sling, synthetic polymer
Virtue by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Male stress urinary incontinence surgical mesh-sling, synthetic polymer.
- AdVance™ XP — Boston Scientific · 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
- Coloplast A/S
Sources (1)
- FDA UDI 64dce22b-873e-4cc8-9590-07d005273153 36 fields · synced Jun 6, 2026