Identity
- Trade Name
- TIELLE® SILICONE BORDER FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Hydropolymer Dressing with Silicone FDA UDI
- Model / Reference
- TLSB2122EN FDA UDI
- Description
- Hydropolymer Dressing with Silicone FDA UDI
Identifiers
- Catalog Number
- TLSB2122EN FDA UDI
- Primary DI / UDI-DI
- 15051978005759 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 21 Centimeter FDA UDILength — 22 Centimeter FDA UDI
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Tielle® Silicone Border by Systagenix Wound Management, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Systagenix Wound Management, Limited
Sources (1)
- FDA UDI fb3f37a7-2231-4c89-90b1-d4dc622212f7 36 fields · synced Jun 8, 2026