Invotec ENT Bur

FDA UDI

Class I (US FDA UDI)

by Invotec International, Inc.

Identity

Trade Name: Invotec ENT Bur FDA UDI
Generic Name: Metal/carbide ENT bur, single-use FDA UDI
Device Name: CARBIDE BUR 2.0mm X 70mm, FLUTES: 6 Notched End FDA UDI
Model / Reference: BC-70200 FDA UDI
Description: CARBIDE BUR 2.0mm X 70mm, FLUTES: 6 Notched End FDA UDI

Identifiers

Catalog Number: BC-70200 FDA UDI
Primary DI / UDI-DI: 00818501021406 FDA UDI
FDA Product Code: EQJ FDA UDI
GMDN Term: Metal/carbide ENT bur, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4140 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Category: Metal/carbide ENT bur, single-use

Invotec ENT Bur by Invotec International, Inc. — 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: Invotec International, Inc.

Sources (1)

FDA UDI 226a5818-1d0a-46c2-899d-5aebff67d9fd 34 fields · synced Jun 9, 2026