Vulcan Saphyre

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: VULCAN SAPHYRE FDA UDI
Generic Name: Stereotactic surgery system probe, reusable FDA UDI
Device Name: VULCAN SAPHYRE II ABLATION PROBE WITH SUCTION, 90 DEGREE, PEWTER SHAFT FDA UDI
Model / Reference: 7210111 FDA UDI
Description: VULCAN SAPHYRE II ABLATION PROBE WITH SUCTION, 90 DEGREE, PEWTER SHAFT FDA UDI

Identifiers

Catalog Number: 7210111 FDA UDI
Primary DI / UDI-DI: 03596010481498 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Stereotactic surgery system probe, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Stereotactic surgery system probe, reusable

Vulcan Saphyre by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stereotactic surgery system probe, reusable.

Head Pin 2.5x60mm, 10 pack w/o CE — MAZOR ROBOTICS LTD · Class II
Rear Panel Adaptor — MAZOR ROBOTICS LTD · Class II
SIES-Long Tapered Drill 3x80, 5 pack — MAZOR ROBOTICS LTD · Class II
Renaissance Surgical Accessories Kit — MAZOR ROBOTICS LTD · Class II
5.5/6.0 Arm Guide Screw Kit — MAZOR ROBOTICS LTD · Class II
SURGICAL_INSTRUMENTS, BED CONNECTOR — MAZOR ROBOTICS LTD · Class II
SA 3.0mm Short Drill, 10 pack — MAZOR ROBOTICS LTD · Class II
SA Long Cannula — MAZOR ROBOTICS LTD · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI 26beb97c-c7c2-4b71-bd3e-85bcf601c489 35 fields · synced Jun 8, 2026