Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Bone cutter FDA UDI
- Device Name
- E-BS2L surgery tip compatible with EMS HYGITECH Reference: HY-98201 Bone saw oriented to the left, allowing the cutting of cortical ceramic bone. Used primarily to perform vertical or horizontal osteotomy cuts on the patient's right or left mandible FDA UDI
- Model / Reference
- HY-98201 FDA UDI
- Description
- E-BS2L surgery tip compatible with EMS HYGITECH Reference: HY-98201 Bone saw oriented to the left, allowing the cutting of cortical ceramic bone. Used primarily to perform vertical or horizontal osteotomy cuts on the patient's right or left mandible FDA UDI
Identifiers
- Catalog Number
- HY-98201 FDA UDI
- Primary DI / UDI-DI
- 03615140005456 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 d424acd7-17c5-44f9-bbae-d1ec73e608e3 34 fields · synced May 30, 2026