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.

Stradis Medical, LLC · Orthopedic Tray → General & Plastic Surgery

Name: Stradis Medical, LLC
Brand: Stradis Medical, LLC

1manufacturer

7catalogue 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 Stradis Medical, LLC
Listed by	Stradis Healthcare, United States
FDA product code	OJH
Device type	Orthopedic Tray
Device class	Class 1
Regulation	21 CFR 878.4800
Premarket notification	Exempt
Record published	2020-06-04
Record revised	2023-01-26 (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	Outer box of 30
Distribution end date	2023-01-25

Catalogue Numbers

Catalogue numbers for Stradis Medical, LLC
Catalogue number	Size	Status
OHI-1000		In distribution
570-0600		In distribution
570-2949		Withdrawn
570-2945		Withdrawn
570-2947		Withdrawn
570-2948		Withdrawn
570-2946		Withdrawn

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 Stradis Medical, LLC
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Stradis Medical, LLC dba Stradis Healthcare	UDI-DI	2022-11-02	Class II	Packaging process control	Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.	144 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.

Stradis Medical, LLC