Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Bone cutter FDA UDI
- Device Name
- IM2P surgery tip compatible Mectron HYGITECH Reference: HY-98033 Surgery tip with marking used during the preparation of the implant bed, especially for bone perforation. Particularly effective in the case of pilot osteotomy in the anterior and posterior (maxillary) region, or optional to check the alignment of the axis of the preparations 2 PIN 2-2.4 Diameter: 2 mm FDA UDI
- Model / Reference
- HY-98033 FDA UDI
- Description
- IM2P surgery tip compatible Mectron HYGITECH Reference: HY-98033 Surgery tip with marking used during the preparation of the implant bed, especially for bone perforation. Particularly effective in the case of pilot osteotomy in the anterior and posterior (maxillary) region, or optional to check the alignment of the axis of the preparations 2 PIN 2-2.4 Diameter: 2 mm FDA UDI
Identifiers
- Catalog Number
- HY-98033 FDA UDI
- Primary DI / UDI-DI
- 03615140005661 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 512b8ee1-e78d-49ce-b5b5-98aac4b539a5 34 fields · synced Jun 1, 2026