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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
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Device Name
ELAN 4 1-RING NEURO PRECISE D3.0 FDA UDI
Model / Reference
US795SU FDA UDI
Description
ELAN 4 1-RING NEURO PRECISE D3.0 FDA UDI

Identifiers

Catalog Number
US795SU FDA UDI
Primary DI / UDI-DI
04046955212095 FDA UDI
FDA Product Code
HBE FDA UDI
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable 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: Bone/joint surgical power tool motorized handpiece/set, electric, reusable

The ELAN 4 is a highly versatile and accurate neuroprecise surgical power tool designed for precise bone and tough tissue drilling, cutting, and inserting procedures in various surgical specialties. With its electrically-powered one-piece design, the ELAN 4 offers exceptional precision and reliability, making it an ideal choice for surgeons and medical professionals.

Similar devices

Also classified as Bone/joint surgical power tool motorized handpiece/set, electric, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesculap, Inc.

Sources (1)

  • FDA UDI 90821115-aeba-436a-8472-0e5ad25e20ab 35 fields · synced Jul 30, 2026