What is FDA product code OEZ?

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. · Cardiovascular Procedure Kit → Cardiovascular

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

1manufacturer

4catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OEZ
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	OEZ
Device type	Cardiovascular Procedure Kit
Device class	Class 2
Regulation	21 CFR 870.1200
Premarket notification	Exempt
Record published	2022-05-17
Record revised	2022-11-30 (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 24
Distribution end date	2023-01-25

Catalogue Numbers

Catalogue numbers for Stradis Medical, LLC.
Catalogue number	Size	Status
TMBRF-594		In distribution
888-2390 R1		Withdrawn
570-2891		Withdrawn
570-2901		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	40,731
Medline Industries, Inc.	Medline Industries, Inc.	17,468
Avid TruCustom	Avid Medical, Inc.	2,785
Namic	Medline Industries, Inc.	2,718
Merit Medical®	Merit Medical Systems, Inc.	2,399
Halyard	Avid Medical, Inc.	2,108
ACS	American Contract Systems, Inc.	1,540
Medline	Medline Industries, Inc.	428
Stradis Healthcare	Stradis Healthcare	263
Regard™	ROi CPS LLC	192
Stradis	Stradis Healthcare	108
Regard™	Resource Optimization & Innovation, L.L.C.	72

Showing 12 of 52. All products under Cardiovascular Procedure Kit

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.