Elan 4

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name: ELAN 4 FDA UDI
Generic Name: Burring power tool attachment FDA UDI
Device Name: AESCULAP ROUND BURR 2.4X70MM FDA UDI
Model / Reference: MD703 FDA UDI
Description: AESCULAP ROUND BURR 2.4X70MM FDA UDI

Identifiers

Catalog Number: MD703 FDA UDI
Primary DI / UDI-DI: 04046964840869 FDA UDI
FDA Product Code: GEY FDA UDI
GMDN Term: Burring power tool attachment FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Burring power tool attachment

Elan 4 by Aesculap, 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: Aesculap, Inc.

Sources (1)

FDA UDI 9e5afa79-44b4-424e-8d48-8cde7c6a8c63 35 fields · synced May 31, 2026