Renaissance System (Refurbished)

FDA UDI

Class II (US FDA UDI)

by Mazor Robotics Ltd

Identity

Trade Name: Renaissance System (Refurbished) FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Model / Reference: TPL0038-0R FDA UDI

Identifiers

Primary DI / UDI-DI: 07290109180410 FDA UDI
FDA Product Code: HAW FDA UDI
LLZ FDA UDI
GMDN Term: Multi-purpose stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
892.2050 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Multi-purpose stereotactic surgery system

Renaissance System (Refurbished) by Mazor Robotics Ltd — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Mazor Robotics Ltd

Sources (1)

FDA UDI 9ea9999a-9b00-42c3-ba2d-8d79dc330e6a 33 fields · synced Jun 1, 2026