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.

Cardiovascular › DiagnosticCardiovascular Procedure Kit

KyphoFlex™

Name: KyphoFlex™
Brand: KyphoFlex™

Catalogue number Initial Release, listed by Merit Medical Systems, Inc., United States, under Cardiovascular Procedure Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

10recalls on this code

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 KyphoFlex™
Listed by	Merit Medical Systems, Inc., United States
FDA product code	OEZ
Device type	Cardiovascular Procedure Kit
Device class	Class 2
Regulation	21 CFR 870.1200
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2024-09-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for KyphoFlex™
Catalogue number	Size	Status
Initial Release		In distribution

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

5 of these are Class II. Class II means a temporary or reversible health consequence. 3 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2025-12-04	Class II	Process control	Inflation device handle may detach from the syringe during procedure.	2192 units
2025-06-05	Class II	Process control	High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.	6327
2024-06-11	Class II	No Marketing Application	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.	188837 kits
2024-06-11	Class II	No Marketing Application	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.	168157 kits
2024-06-11	Class II	No Marketing Application	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.	69 kits
2009-01-29	Not classified	Process control	A manufacturing defect may prevent adequate sterilization of the entire device.	157 units	2011-06-16
2009-01-29	Not classified	Process control	A manufacturing defect may prevent adequate sterilization of the entire device.	220 units	2011-06-16
2009-01-29	Not classified	Process control	A manufacturing defect may prevent adequate sterilization of the entire device.	145 units	2011-06-16
2009-01-29	Not classified	Process control	A manufacturing defect may prevent adequate sterilization of the entire device.	20 units	2011-06-16
2009-01-29	Not classified	Process control	A manufacturing defect may prevent adequate sterilization of the entire device.	368 units	2011-06-16

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.