Aesculap

FDA UDI

Class I (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name: AESCULAP FDA UDI
Generic Name: Neurosurgical microscope FDA UDI
Device Name: SOFTWARE MODULE DICOM FDA UDI
Model / Reference: PV024 FDA UDI
Description: SOFTWARE MODULE DICOM FDA UDI

Identifiers

Catalog Number: PV024 FDA UDI
Primary DI / UDI-DI: 04046955206810 FDA UDI
FDA Product Code: LMB FDA UDI
GMDN Term: Neurosurgical microscope FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.2010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Neurosurgical microscope

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

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Also classified as Neurosurgical microscope.

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OPMI® PENTERO® 900 — Carl Zeiss Meditec AG · Class I
BLUE 400 — Carl Zeiss Meditec AG · Class I
RE3 — DIGITAL SURGERY SYSTEMS, INC · Class I
Surgical Microscope MM80/YOH — MITAKA KOHKI CO., LTD. · Class I
Surgical Microscope MM80/SS1 — MITAKA KOHKI CO., LTD. · Class I

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 1bd2927f-228e-463a-9eb1-5324d02cb10f 35 fields · synced May 30, 2026