7D Surgical Cranial Pointer

FDA UDI

Class II (US FDA UDI)

by 7D Surgical ULC

Identity

Trade Name: 7D Surgical Cranial Pointer FDA UDI
Generic Name: Stereotactic surgery system probe, reusable FDA UDI
Model / Reference: 11-0009 FDA UDI

Identifiers

Primary DI / UDI-DI: 00627843746690 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Stereotactic surgery system probe, reusable 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Stereotactic surgery system probe, reusable

7D Surgical Cranial Pointer by 7D Surgical ULC — 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
ACUFEX — Smith & Nephew, Inc. · 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 II	Pending data

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

Manufacturer

Manufacturer: 7D Surgical ULC

Sources (1)

FDA UDI 137a9435-b5f1-4e6e-b19f-7e5356250a4e 32 fields · synced Jun 1, 2026