10736ROI Dual Tip Mrkr, Reg Gentian Violet/Permanent Ink w/Ruler and Labels PL

FDA UDI

Class I (US FDA UDI)

by Xodus Medical, Inc.

Identity

Trade Name: 10736ROI Dual Tip Mrkr, Reg Gentian Violet/Permanent Ink w/Ruler and Labels PL FDA UDI
Generic Name: Skin marking pen, single-use FDA UDI
Device Name: 10736ROI Dual Tip Marker, Regular Tip Gentian Violet and Regular Tip Permanent Ink w/ Ruler and Labels PL FDA UDI
Model / Reference: 10736ROI FDA UDI
Description: 10736ROI Dual Tip Marker, Regular Tip Gentian Violet and Regular Tip Permanent Ink w/ Ruler and Labels PL FDA UDI

Identifiers

Catalog Number: 10736ROI FDA UDI
Primary DI / UDI-DI: 00787551008562 FDA UDI
FDA Product Code: FZZ FDA UDI
GMDN Term: Skin marking pen, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Skin marking pen, single-use

10736ROI Dual Tip Mrkr, Reg Gentian Violet/Permanent Ink w/Ruler and Labels PL by Xodus Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Skin marking pen, single-use.

MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
WriteSite® Jr. Small Preoperative Skin Marker — Aspen Surgical Products, Inc. · Class I
Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
Richard-Allan® Utility Marker with Labels — Aspen Surgical Products, Inc. · Class I
Richard-Allan® Fine Tip Utility Pen — Aspen Surgical Products, Inc. · Class I
Bioseal Inc. — BIOSEAL · Class I
Medical Action Industries — MEDICAL ACTION INDUSTRIES 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 I	Pending data

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

Manufacturer

Manufacturer: Xodus Medical, Inc.

Sources (1)

FDA UDI 6db122af-8c14-47d4-812e-60e749af319f 35 fields · synced Jun 1, 2026