What is FDA product code OII?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Radiology › DiagnosticArthrogram Tray

Arthrogram Tray

Name: Arthrogram Tray
Brand: Arthrogram Tray

Arthrogram Drug Free Tray, For Double and Single Contrast Arthrography

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code OII
Manufacturer	City	Province	Registered as	Device types
Weifang Dragonfly Electronic Technology Co., Ltd.	Weifang	Shandong	Manufacturer	9

Record

Regulatory record for Arthrogram Tray
Listed by	Carefusion 2200, Inc., United States
FDA product code	OII
Device type	Arthrogram Tray
Device class	Class 2
Regulation	21 CFR 892.1650
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2016-09-23
Record revised	2023-12-11 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 20 to 25 °C
Packaging	Case of 10
Distribution end date	2023-12-11

Catalogue Numbers

Catalogue numbers for Arthrogram Tray
Catalogue number	Size	Status
4325DF		In distribution
4325		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	2,043
Cardinal Health	Cardinal Health 200, LLC	596
Busse Hospital Disposables	Robert Busse & Co., Inc.	24
Medline	Medline Industries, Inc.	6
Busse Hosptial Disposables	Robert Busse & Co., Inc.	1
ACS	American Contract Systems, Inc.	1
Safe-T	Carefusion 2200, Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.