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Invotec ENT Bur

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref BC-70350PModel ENT Bur

by Invotec International, Inc.

Identity

Trade Name
Invotec ENT Bur FDA UDI
Generic Name
Metal/carbide ENT bur, single-use FDA UDI
Device Name
ENT Bur EUDAMED
CARBIDE BUR 3.5mm X 70mm, FLUTES: 8 PLAIN SHAFT FDA UDI
Model / Reference
BC-70350P EUDAMEDFDA UDI
ENT Bur EUDAMED
Description
CARBIDE BUR 3.5mm X 70mm, FLUTES: 8 PLAIN SHAFT FDA UDI

Identifiers

Catalog Number
BC-70350P FDA UDI
Primary DI / UDI-DI
00818501021475 EUDAMEDFDA UDI
Basic UDI-DI
081850102ENTBursN5 EUDAMED
FDA Product Code
EQJ FDA UDI
EMDN Code
Q0399 ENT DEVICES - OTHER EUDAMED
GMDN Term
Metal/carbide ENT bur, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
874.4140 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Invotec ENT Bur by Invotec International, Inc. — Class I — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Invotec International, Inc.

Sources (2)

  • FDA UDI c192d739-3119-4a17-b7eb-8cf3735c2679 34 fields · synced Oct 6, 2026
  • EUDAMED 5c1c5492-d347-4371-b4e3-1f8703dacb89 61 fields · synced Jul 10, 2026