Zeos

FDA UDI

Class II (US FDA UDI)

by Santa Barbara Imaging Systems, Inc.

Identity

Trade Name: ZEOS FDA UDI
Generic Name: Rigid optical arthroscope, reusable FDA UDI
Device Name: HIP ARTHROSCOPE, 4MM 70DEG FDA UDI
Model / Reference: 84-14-4270 FDA UDI
Description: HIP ARTHROSCOPE, 4MM 70DEG FDA UDI

Identifiers

Primary DI / UDI-DI: 00812231032060 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Rigid optical arthroscope, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
Commercial Distribution: 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

Category: Rigid optical arthroscope, reusable

Zeos by Santa Barbara Imaging Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Rigid optical arthroscope, reusable.

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HOPKINS — Karl Storz GmbH & Co. KG · Class II
Olympus — Olympus Winter & Ibe GmbH · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
HOPKINS — Karl Storz GmbH & Co. KG · Class II
Precision Ideal Eyes — Stryker Corp. · Class II

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: Santa Barbara Imaging Systems, Inc.

Sources (1)

FDA UDI 3e02850b-e790-467b-9dad-0f1b9194c29d 34 fields · synced May 29, 2026