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Align® RS Retropubic/Suprapubic Urethral Support System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Align® RS Retropubic/Suprapubic Urethral Support System FDA UDI
- Generic Name
- Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
- Device Name
- ALIGN® Urethral Support System, Retropubic & Suprapubic FDA UDI
- Model / Reference
- BRD300RS FDA UDI
- Description
- ALIGN® Urethral Support System, Retropubic & Suprapubic FDA UDI
Identifiers
- Catalog Number
- BRD300RS FDA UDI
- Primary DI / UDI-DI
- 00801741016196 FDA UDI
- FDA Product Code
- OTN FDA UDI
- GMDN Term
- Female 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
- Not 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
Align® RS Retropubic/Suprapubic Urethral Support System by C. R. Bard, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
Sources (1)
- FDA UDI dc34b713-abbf-4ded-ae3b-26a470862685 36 fields · synced May 30, 2026