Identity
- Trade Name
- SI-RESTORE FDA UDI
- Generic Name
- Endoscopic soft-tissue release system dilator/gauge FDA UDI
- Device Name
- SMOOTH DILATOR 3 FDA UDI
- Model / Reference
- 1701-300055 FDA UDI
- Description
- SMOOTH DILATOR 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850073363393 FDA UDI
- 510(k) Number
- K182919 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Endoscopic soft-tissue release system dilator/gauge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic soft-tissue release system dilator/gauge
Si-Restore by Biofusion Management And Manufacturing, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic soft-tissue release system dilator/gauge.
- MicroAire® — MicroAire Surgical Instruments LLC · Class I
- MicroAire® — MicroAire Surgical Instruments LLC · Class I
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · Class I
- MicroAire® — MicroAire Surgical Instruments LLC · Class I
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · Class I
Cleared under the same submission
K182919 also covers:
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
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
- Biofusion Management And Manufacturing, Llc
Sources (1)
- FDA UDI 3ffb6cb4-66e4-420f-af6f-c08058725f63 34 fields · synced Jun 8, 2026