10735 Dual Tip Marker +1 more model

FDA UDI

Class I (US FDA UDI)

by Xodus Medical, Inc.

Identity

Trade Name: 10735 Dual Tip Marker; Regular Tip Gentian Violet and Regular Tip Permanent Ink FDA UDI
Generic Name: Skin marking pen, single-use FDA UDI
Device Name: 10735 Dual Tip Marker; Regular Tip Gentian Violet and Regular Tip Permanent Ink FDA UDI
Model / Reference: 10735 FDA UDI
Description: 10735 Dual Tip Marker; Regular Tip Gentian Violet and Regular Tip Permanent Ink FDA UDI

Identifiers

Catalog Number: 10735 FDA UDI
Primary DI / UDI-DI: 00787551003116 FDA UDI
FDA Product Code: FZZ FDA UDI
GMDN Term: Skin marking pen, single-use FDA UDI
Models / Variants: 10735 Dual Tip Marker FDA UDI
Regular Tip Gentian Violet and Regular Tip Permanent Ink 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

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

10735 Dual Tip Marker +1 more model by Xodus Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — 2 models — 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 I	Pending data

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Manufacturer

Manufacturer: Xodus Medical, Inc.

Sources (1)

FDA UDI 51b96406-673c-42e8-b433-5768e0b01985 35 fields · synced Jun 8, 2026