Imaging

FDA UDI

Class I (US FDA UDI)

by Santa Barbara Imaging Systems, Inc.

Identity

Trade Name: Imaging FDA UDI
Generic Name: Endoscope camera adaptor FDA UDI
Device Name: ZOOM Coupler, F=16-34MM FDA UDI
Model / Reference: 87-10-2020 FDA UDI
Description: ZOOM Coupler, F=16-34MM FDA UDI

Identifiers

Catalog Number: 87-10-2020 FDA UDI
Primary DI / UDI-DI: 00853460007559 FDA UDI
FDA Product Code: FEM FDA UDI
GMDN Term: Endoscope camera adaptor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1500 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

Yes

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: Endoscope camera adaptor

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

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Fibre optic cable adpater — JOIMAX, INC. · Class I

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: Santa Barbara Imaging Systems, Inc.

Sources (1)

FDA UDI 6f4067cc-c139-4327-a9e4-71cbe291e3db 35 fields · synced Jun 8, 2026