Hygitech

FDA UDI

Class I (US FDA UDI)

by Hygitech

Identity

Trade Name: HYGITECH FDA UDI
Generic Name: Bone cutter FDA UDI
Device Name: E-SL1 surgery tip compatible EMS HYGITECH Reference: HY-98211 Flat diamond insert used mainly in the following surgical procedures: • Cutting the vestibular bone flap • Sharp angle attenuation FDA UDI
Model / Reference: HY-98211 FDA UDI
Description: E-SL1 surgery tip compatible EMS HYGITECH Reference: HY-98211 Flat diamond insert used mainly in the following surgical procedures: • Cutting the vestibular bone flap • Sharp angle attenuation FDA UDI

Identifiers

Catalog Number: HY-98211 FDA UDI
Primary DI / UDI-DI: 03615140005401 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

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 8ed5b7fb-ac1c-4fe9-b02e-64a05522f9e4 34 fields · synced Jun 8, 2026