Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Bone cutter FDA UDI
- Device Name
- IM3P surgery tip compatible Mectron HYGITECH Reference: HY-98034 Surgery tip with marking and double irrigation (to avoid overheating in the maxilla). Necessary for the preparation of the implant site and in particular for bone perforation. Used in two concrete clinical applications: • For implant site expansion • To complete the preparation of the implant bed Diameter: 3 mm FDA UDI
- Model / Reference
- HY-98034 FDA UDI
- Description
- IM3P surgery tip compatible Mectron HYGITECH Reference: HY-98034 Surgery tip with marking and double irrigation (to avoid overheating in the maxilla). Necessary for the preparation of the implant site and in particular for bone perforation. Used in two concrete clinical applications: • For implant site expansion • To complete the preparation of the implant bed Diameter: 3 mm FDA UDI
Identifiers
- Catalog Number
- HY-98034 FDA UDI
- Primary DI / UDI-DI
- 03615140005692 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 ade23294-72e8-4d53-afa6-b03f827a796a 34 fields · synced May 29, 2026