What is FDA product code OJH?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. 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.

Centurion Medical Products Corp · Orthopedic Tray → General & Plastic Surgery

Name: Centurion Medical Products Corp
Brand: Centurion Medical Products Corp

1manufacturer

18catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

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

Record

Regulatory record for Centurion Medical Products Corp
Listed by	Medline Industries, Inc., United States
FDA product code	OJH
Device type	Orthopedic Tray
Device class	Class 1
Regulation	21 CFR 878.4800
Premarket notification	Exempt
Record published	2023-06-25
Record revised	2023-07-28 (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
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Case of 20, case of 5, case of 10, case of 15, case of 24, case of 11
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Centurion Medical Products Corp
Catalogue number	Size	Status
MNS15155		In distribution
DT22780A		In distribution
MNS13870		In distribution
SB1465		In distribution
MNS14055		In distribution
MNS13470		In distribution
MNS8445		In distribution
MNS12645A		In distribution
PT235A		In distribution
MNS13420A		In distribution
MNS14030		In distribution
MNS14065		In distribution
MNS15280		In distribution
MNS13410		In distribution
MNS15560		In distribution
MNS15240		In distribution
MNS14090		In distribution
MNS13385		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	95,039
Medline Industries, Inc.	Medline Industries, Inc.	53,097
Avid TruCustom	Avid Medical, Inc.	3,990
ACS	American Contract Systems, Inc.	3,812
Halyard	Avid Medical, Inc.	1,313
Aligned Medical Solutions	Aligned Medical Solutions	1,272
Regard™	ROi CPS LLC	464
Overwatch	Spinal Elements, Inc.	223
Regard™	Resource Optimization & Innovation, L.L.C.	191
Lucent L	Spinal Elements, Inc.	95
Invenio	GRI Medical & Electronic Technology Co., Ltd.	87
Integra®	Ascension Orthopedics, Inc.	81

Showing 12 of 367. All products under Orthopedic Tray

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Centurion Medical Products Corp
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2022-12-07	Class II	Under Investigation by firm	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.	4779 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.

Centurion Medical Products Corp