Estremo

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: ESTREMO FDA UDI
Generic Name: Medical ruler, single-use FDA UDI
Model / Reference: Nails ruler kit with wire 1000mm FDA UDI

Identifiers

Catalog Number: DT030063 FDA UDI
Primary DI / UDI-DI: 08051739531602 FDA UDI
510(k) Number: K181540 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Medical ruler, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 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

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: Medical ruler, single-use

Estremo by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Medical ruler, single-use.

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NS10203 Coated Ruler Printed #4000 8PT C1S — XODUS MEDICAL, INC. · Class I
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Grafco — GF Health Products, Inc · Class I
Grafco — GF Health Products, Inc · Class I

Cleared under the same submission

K181540 also covers:

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

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Manufacturer

Manufacturer: Citieffe

Sources (1)

FDA UDI 00d28386-e20a-4ab5-b0c4-5925ed3ac553 36 fields · synced Jun 8, 2026