What is FDA product code PXO?

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.

Stradis · Bone Marrow Biopsy Tray → General & Plastic Surgery

Name: Stradis
Brand: Stradis

1manufacturer

2catalogue numbers in this listing

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code PXO
Manufacturer	City	Province	Registered as	Device types
Shanghai Lange Medtech Co., Ltd.	Shanghai	Shanghai	Manufacturer	16

Record

Regulatory record for Stradis
Listed by	Stradis Healthcare, United States
FDA product code	PXO
Device type	Bone Marrow Biopsy Tray
Device class	Class 1
Regulation	21 CFR 878.4800
Premarket notification	Exempt
Record published	2022-08-09
Record revised	2023-01-30 (version 2)

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
Distribution end date	2023-01-27

Catalogue Numbers

Catalogue numbers for Stradis
Catalogue number	Size	Status
570-3092		In distribution
570-3091		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	50
Centurion	Centurion Medical Products Corporation	7
Medline	Medline Industries, Inc.	7
Bone Access Kit	Custom Interventional Pain Management	3
Vygon	Vygon Corp.	2
Henry Schein	Henry Schein, Inc.	2

Recalls Naming This Product

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

Recalls naming the identifiers of Stradis
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.	581 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