Identity
- Trade Name
- Softspan™ Tissue Expander FDA UDI
- Generic Name
- Skin-port tissue expander FDA UDI
- Device Name
- Softspan™ Tissue Expander, Low Rectangle, Remote Injection Port, Smooth Surface, Reinforced Base FDA UDI
- Model / Reference
- SRE-LR-160S FDA UDI
- Description
- Softspan™ Tissue Expander, Low Rectangle, Remote Injection Port, Smooth Surface, Reinforced Base FDA UDI
Identifiers
- Catalog Number
- SRE-LR-160S FDA UDI
- Primary DI / UDI-DI
- M746SRELR160S0 FDA UDI
- FDA Product Code
- LCJ FDA UDI
- GMDN Term
- Skin-port tissue expander FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 10.0 Centimeter FDA UDI
Softspan™ Tissue Expander by Specialty Surgical Products, Inc. — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Specialty Surgical Products, Inc.
Sources (1)
- FDA UDI bc48223f-d7a7-401e-874c-3584fa7fde88 37 fields · synced Jun 8, 2026