What is FDA product code OJG?

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.

Neurology › SurgicalNeurological Tray

Integra® Ruggles®-Redmond™

Name: Integra® Ruggles®-Redmond™
Brand: Integra® Ruggles®-Redmond™

Integra® Ruggles®-Redmond™ Rhoton-Type Microsurgery Dissection Expanded Set, 19 Instruments and Tray

Registry build 21.09.26

1manufacturer

3catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OJG
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for Integra® Ruggles®-Redmond™
Listed by	Integra LifeSciences Production Corporation, United States
FDA product code	OJG
Device type	Neurological Tray
Device class	Class 1
Regulation	21 CFR 882.4525
Establishment	Contract manufacturer, Specification developer, Manufacturer
Premarket notification	Exempt
Record published	2016-08-23
Record revised	2020-02-05 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number
Distribution end date	2018-10-16
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Integra® Ruggles®-Redmond™
Catalogue number	Size	Status
RN6230		In distribution
RN6200		In distribution
RN5000		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	25,194
Medline Industries, Inc.	Medline Industries, Inc.	3,084
Avid TruCustom	Avid Medical, Inc.	969
ACS	American Contract Systems, Inc.	938
Halyard	Avid Medical, Inc.	718
Regard™	ROi CPS LLC	208
Regard™	Resource Optimization & Innovation, L.L.C.	55
Aligned Medical Solutions	Aligned Medical Solutions	53
V. Mueller	Steris Corporation	27
Nico BrainPath Approach	Nico Corporation	25
V. Mueller	Carefusion 2200, Inc.	13
Invenio	GRI Medical & Electronic Technology Co., Ltd.	11

Showing 12 of 24. All products under Neurological Tray

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.