Camino®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences (ireland) Limited

Identity

Trade Name: Camino® FDA UDI
Generic Name: Electrical-only medical device connection cable, reusable FDA UDI
Device Name: The Integra Camino Flex Extension Cable is used to connect the Integra Camino Flex Catheter to the Integra Camino ICP Monitor. It is an eight foot long silicone cable, with circular PEI (polyetherimide) connectors and a Ferrite clamp on suppressor. FDA UDI
Model / Reference: FLEXEXT FDA UDI
Description: The Integra Camino Flex Extension Cable is used to connect the Integra Camino Flex Catheter to the Integra Camino ICP Monitor. It is an eight foot long silicone cable, with circular PEI (polyetherimide) connectors and a Ferrite clamp on suppressor. FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780040965 FDA UDI
510(k) Number: K121159 FDA UDI
FDA Product Code: GWM FDA UDI
GMDN Term: Electrical-only medical device connection cable, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1620 FDA UDI
Commercial Distribution: Not 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

MRI Safety

MR Unsafe FDA UDI

Camino® by Integra Lifesciences (ireland) Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K121159 also covers:

CAMINO® — Natus Medical Incorporated

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: Integra Lifesciences (ireland) Limited

Sources (1)

FDA UDI 018c63ef-4faf-4cd6-bb03-b56bf212a632 38 fields · synced May 30, 2026