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.

Medline · Neurological Tray → Neurology

Name: Medline
Brand: Medline

1manufacturer

4catalogue 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 Medline
Listed by	Medline Industries, Inc., United States
FDA product code	OJG
Device type	Neurological Tray
Device class	Class 1
Regulation	21 CFR 882.4525
Premarket notification	Exempt
Record published	2021-08-18
Record revised	2022-06-17 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
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
Packaging	Case of 15
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Medline
Catalogue number	Size	Status
CDS780162AB		In distribution
CDS780109O		In distribution
DYNJ23052G		In distribution
NAM0003A		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
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

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Medline
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2026-03-19	Class II	Under Investigation by firm	During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.	538201 kits
Medline Industries, LP – Northfield	UDI-DI	2024-11-21	Class II	Nonconforming Material/Component	Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.	205360 units

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.

Medline