Identity
- Trade Name
- T-SLING FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
- Device Name
- The code 5194001400, brand name “T-Sling” where T stands for tension-free, is a medical device entirely made in Polypropylene monofilament used for the treatment of stress urinary incontinence (SUI). FDA UDI
- Model / Reference
- 5194001400 FDA UDI
- Description
- The code 5194001400, brand name “T-Sling” where T stands for tension-free, is a medical device entirely made in Polypropylene monofilament used for the treatment of stress urinary incontinence (SUI). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28032919892120 FDA UDI
- FDA Product Code
- PAH FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
T-Sling by Herniamesh — 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
- Herniamesh
Sources (1)
- FDA UDI b2c7c6f7-2e15-4e7c-b66b-32c730b84b4c 34 fields · synced May 30, 2026