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Elan 4

FDA UDI

Class II (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name
ELAN 4 FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Device Name
ELAN 4 1-RING DISP.DIAM.BURR COARSE D2.3 FDA UDI
Model / Reference
GP163SU FDA UDI
Description
ELAN 4 1-RING DISP.DIAM.BURR COARSE D2.3 FDA UDI

Identifiers

Catalog Number
GP163SU FDA UDI
Primary DI / UDI-DI
04046955152063 FDA UDI
FDA Product Code
HBE FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bur, single-use

Elan 4 by Aesculap, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesculap, Inc.

Sources (1)

  • FDA UDI b2c0ac0d-5fd6-486c-b953-3f5470c259bf 35 fields · synced May 31, 2026