Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Bone cutter FDA UDI
- Device Name
- V-SL4 surgery tip compatible Satelec HYGITECH Reference: HY-98115 Indicated in sinus lift techniques, this 90° angled non-cutting spatula allows the sinus membrane to be lifted deep inside the sinus. Diameter of the spatula: 4mm Compatible with : Piezotome Solo (LED), Piezotome 2, Implant Center™ 2 FDA UDI
- Model / Reference
- HY-98115 FDA UDI
- Description
- V-SL4 surgery tip compatible Satelec HYGITECH Reference: HY-98115 Indicated in sinus lift techniques, this 90° angled non-cutting spatula allows the sinus membrane to be lifted deep inside the sinus. Diameter of the spatula: 4mm Compatible with : Piezotome Solo (LED), Piezotome 2, Implant Center™ 2 FDA UDI
Identifiers
- Catalog Number
- HY-98115 FDA UDI
- Primary DI / UDI-DI
- 03615140005531 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Bone cutter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone cutter
Hygitech by Hygitech — 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
- Hygitech
Sources (1)
- FDA UDI 0bb99c2f-b7f9-4c47-ad9a-64694652ec2f 34 fields · synced May 30, 2026