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

Nico BrainPath Approach

Name: Nico BrainPath Approach
Brand: Nico BrainPath Approach

BP & Illumination Pack [13.5x60 mm + PB1113 + SelectLock(G) + meniG + SecureH] + [11GA Illum]

Registry build 21.09.26

1manufacturer

25catalogue 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 Nico BrainPath Approach
Listed by	Nico Corporation, United States
FDA product code	OJG
Device type	Neurological Tray
Device class	Class 1
Regulation	21 CFR 882.4525
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2021-04-05
Record revised	2019-02-22 (version 3)

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
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Nico BrainPath Approach
Catalogue number	Size	Status
NN-3001		In distribution
NN-3008		In distribution
NN-3004		In distribution
NN-2001		In distribution
NN-3006		In distribution
NN-3003		In distribution
NN-3009		In distribution
NN-3002		In distribution
NN-2027		In distribution
NN-2026		In distribution
NN-3005		In distribution
NN-2005		In distribution
NN-2022		In distribution
NN-2000		In distribution
NN-2006		In distribution
NN-2002		In distribution
NN-2024		In distribution
NN-2023		In distribution
NN-2025		In distribution
NN-2003		In distribution
NN-3007		In distribution
NN-2004		In distribution
NN-3000		In distribution
NN-3010		In distribution
NN-2021		In distribution

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
V. Mueller	Carefusion 2200, Inc.	13
Invenio	GRI Medical & Electronic Technology Co., Ltd.	11
Phasor	Phasor Health, LLC	8

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.