RMAC Surgical

FDA UDI

Class I (US FDA UDI)

by RMAC Surgical, Inc

Identity

Trade Name: RMAC Surgical FDA UDI
Generic Name: Skin marking guide, single-use FDA UDI
Device Name: Skin marker for making clear markings on the skin FDA UDI
Model / Reference: RM-1450XL FDA UDI
Description: Skin marker for making clear markings on the skin FDA UDI

Identifiers

Primary DI / UDI-DI: 00754027700275 FDA UDI
FDA Product Code: FZZ FDA UDI
GMDN Term: Skin marking guide, 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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Skin marking guide, single-use

RMAC Surgical by RMAC Surgical, Inc — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: RMAC Surgical, Inc

Sources (1)

FDA UDI 014949f8-3d2c-4599-a360-873b2d80e808 34 fields · synced May 30, 2026