Invotec ENT Bur

FDA UDI

Class I (US FDA UDI)

by Invotec International, Inc.

Identity

Trade Name: Invotec ENT Bur FDA UDI
Generic Name: Diamond ENT bur, single-use FDA UDI
Device Name: DIAMOND BUR 6.0mm X 70mm PLAIN SHAFT FDA UDI
Model / Reference: BD-70600P FDA UDI
Description: DIAMOND BUR 6.0mm X 70mm PLAIN SHAFT FDA UDI

Identifiers

Catalog Number: BD-70600P FDA UDI
Primary DI / UDI-DI: 00818501021895 FDA UDI
FDA Product Code: EQJ FDA UDI
GMDN Term: Diamond 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: Diamond 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 cb4b7ff6-bf3f-4dfb-a17b-0190b76b35ba 34 fields · synced Jun 9, 2026