Identity
- Trade Name
- Needleless Sling FDA UDI
- Generic Name
- Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
- Model / Reference
- NL-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437007606058 FDA UDI
- FDA Product Code
- PAH 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
- 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Female stress urinary incontinence surgical mesh-sling, synthetic polymer
Needleless Sling by Desarrollo E Investigacion Medica Aragonesa Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Female stress urinary incontinence surgical mesh-sling, synthetic polymer.
- Desara Blue — CALDERA MEDICAL, INC. · Class II
- Desara Blue TVez 3.0 — CALDERA MEDICAL, INC. · Class II
- Lynx™ System — Boston Scientific · Class II
- Desara TV — CALDERA MEDICAL, INC. · Class II
- Solyx™ SIS System — Boston Scientific · Class II
- Exair — Coloplast A/S · Class III
- Desara TV — CALDERA MEDICAL, INC. · Class II
- Desara Blue TVez 2.7 — CALDERA MEDICAL, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Desarrollo E Investigacion Medica Aragonesa Sl
Sources (1)
- FDA UDI 4f16d763-d163-407b-9909-f8cd00c25cb1 32 fields · synced Jun 8, 2026