Aesculap

FDA UDI

Class II (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name: AESCULAP FDA UDI
Generic Name: Robotic surgical navigation system FDA UDI
Device Name: ORTHOPILOT BASIS COMPACT FDA UDI
Model / Reference: FS101 FDA UDI
Description: ORTHOPILOT BASIS COMPACT FDA UDI

Identifiers

Catalog Number: FS101 FDA UDI
Primary DI / UDI-DI: 04046963168933 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Robotic surgical navigation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Robotic surgical navigation system

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

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EXCELSIUSGPS — GLOBUS MEDICAL, INC. · Class II
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EXCELSIUS GPS — GLOBUS MEDICAL, INC. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Aesculap, Inc.

Sources (1)

FDA UDI 6ff2a2a5-7f22-4231-9410-247994ff1646 35 fields · synced Jun 6, 2026