MCI – Medical Concept Innovation, Inc.

Caddy Base FOR Plate 1.5

Registry build 21.09.26
1manufacturer
14catalogue numbers in this listing

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 MCI – Medical Concept Innovation, Inc.
Listed by MCI Medical Concept Innovation Inc., United States
FDA product code PXV
Device type General Purpose Instrument Tray
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-08-08
Record revised 2024-08-09 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for MCI – Medical Concept Innovation, Inc.
Catalogue number Size Status
A02.01.1511 In distribution
A02.01.1514 In distribution
A02.01.2210 In distribution
A02.01.1500 In distribution
A02.01.1503 In distribution
A02.01.1504 In distribution
A02.01.1509 In distribution
A02.01.1512 In distribution
A02.01.1507 In distribution
A02.02.0001 In distribution
A02.02.0002 In distribution
A02.01.1508 In distribution
A02.01.1513 In distribution
A02.02.0003 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
SingleCycle Biohazard Self-Sealing label 25″ Cygnus Medical L.L.C. 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer