Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Bone cutter FDA UDI
- Device Name
- V-PIRAHNA surgery tip compatible Satelec HYGITECH Reference: HY-98126 Double sharpening saw allowing to act both on the depth and on the cutting thickness. Particularly effective for root hemisections and amputations, it is also used to cut the molars included during their extraction Length: 9 mm Compatible with : Piezotome Solo (LED), Piezotome 2, Implant Center™ 2 FDA UDI
- Model / Reference
- HY-98126 FDA UDI
- Description
- V-PIRAHNA surgery tip compatible Satelec HYGITECH Reference: HY-98126 Double sharpening saw allowing to act both on the depth and on the cutting thickness. Particularly effective for root hemisections and amputations, it is also used to cut the molars included during their extraction Length: 9 mm Compatible with : Piezotome Solo (LED), Piezotome 2, Implant Center™ 2 FDA UDI
Identifiers
- Catalog Number
- HY-98126 FDA UDI
- Primary DI / UDI-DI
- 03615140005463 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
Similar devices
Also classified as Bone cutter.
- Zimmer Persona Knee System — Zimmer, Inc. · Class II
- Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
- Novel — ALPHATEC SPINE, INC. · Class I
- Battalion — ALPHATEC SPINE, INC. · Class I
- Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
- Battalion — ALPHATEC SPINE, INC. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class I
- Park Dental Research Corp. — Park Dental Research Corp · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI 91dcac57-740d-4906-bcf9-34991496e5af 34 fields · synced May 30, 2026