What is FDA product code PXV?

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.

General & Plastic Surgery › SurgicalGeneral Purpose Instrument Tray

OsteoCentric Trauma Small Frag Fastener Surgical Case

Name: OsteoCentric Trauma Small Frag Fastener Surgical Case
Brand: OsteoCentric Trauma Small Frag Fastener Surgical Case

Small Frag Fastener Surgical Case including lid, upper instrument tray, lower instrument tray, and screw Caddy

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code PXV
Manufacturer	City	Province	Registered as	Device types
Dongguan Hong De Medical Plastic Products Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	32

Record

Regulatory record for OsteoCentric Trauma Small Frag Fastener Surgical Case
Listed by	OsteoCentric Technologies,Inc, United States
FDA product code	PXV
Device type	General Purpose Instrument Tray
Device class	Class 1
Regulation	21 CFR 878.4800
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2019-10-09
Record revised	2023-08-16 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for OsteoCentric Trauma Small Frag Fastener Surgical Case
Catalogue number	Size	Status
A2200		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MCI – Medical Concept Innovation, Inc.	MCI Medical Concept Innovation Inc.	14
Cardinal Health	Cardinal Health 200, LLC	11
Cygnus	Cygnus Medical L.L.C.	9
BR Surgical, LLC	BR Surgical LLC	8
Headless Screw System Instruments	Tyber Medical	4
Tyber Medical	Tyber Medical	3
Stradis Healthcare	Stradis Healthcare	2
Centurion	Centurion Medical Products Corporation	2
Oasis Biodegradable Scope Transport Tray with Reversible lid	Cygnus Medical L.L.C.	2
SingleCycle Disposable Instrument Tray	Cygnus Medical L.L.C.	2
Bundle – SingleCycle Disposable Instrument Tray and “biohazard/Soiled I	Cygnus Medical L.L.C.	2
OsteoCentric Trauma Small Frag Plate Surgical Case	OsteoCentric Technologies,Inc	1

Showing 12 of 46. All products under General Purpose Instrument Tray

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.