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.

Bone Access Kit · Bone Marrow Biopsy Tray → General & Plastic Surgery

Name: Bone Access Kit
Brand: Bone Access Kit

1manufacturer

3catalogue 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 Bone Access Kit
Listed by	Custom Interventional Pain Management, United States
FDA product code	PXO
Device type	Bone Marrow Biopsy Tray
Device class	Class 1
Regulation	21 CFR 878.4800
Establishment	Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2023-07-19

Specifications

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

Catalogue Numbers

Catalogue numbers for Bone Access Kit
Catalogue number	Size	Status
3404		In distribution
TRAP		In distribution
CTDLID		In distribution

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
Stradis	Stradis Healthcare	2
Vygon	Vygon Corp.	2
Henry Schein	Henry Schein, Inc.	2

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.

Bone Access Kit

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies