FDA.reportPublic FDA data

MCI - Medical Concept Innovation, Inc.

Primary DI
00811687031832
Brand
MCI - Medical Concept Innovation, Inc.
Company
MCI-MEDICAL CONCEPT INNOVATION INC
Model
A02.01.2210
Catalog number
A02.01.2210
Device description
IMF SCREWS CADDY 1
Published
2023-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PXVGeneral Purpose Instrument Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXVGeneral Purpose Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811687031832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811687031832008116870318328116870318320811687031832

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
19543062521customer.service@mci-medical.com

Regulatory Flags#

DUNS number
080815653
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811687032877MCI - Medical Concept Innovation, Inc.A01.01.1137A01.01.11372024-08-27
00811687032884MCI - Medical Concept Innovation, Inc.A01.01.1138A01.01.11382024-08-27
00811687031986MCI - Medical Concept Innovation, Inc.A01.02.1123A01.02.11232024-08-07
00811687031993MCI - Medical Concept Innovation, Inc.A01.02.1011A01.02.10112024-08-07
00811687032006MCI - Medical Concept Innovation, Inc.A01.02.1013A01.02.10132024-08-07
00811687032013MCI - Medical Concept Innovation, Inc.A01.02.1012A01.02.10122024-08-07
00811687032549MCI - Medical Concept Innovation, Inc.A01.01.2310A01.01.23102024-08-07
00811687032556MCI - Medical Concept Innovation, Inc.A01.01.1004A01.01.10042024-08-07
00811687032563MCI - Medical Concept Innovation, Inc.A01.01.3010A01.01.30102024-08-07
00811687032587MCI - Medical Concept Innovation, Inc.A01.02.1101A01.02.11012024-08-07
00811687032594MCI - Medical Concept Innovation, Inc.A01.02.1125A01.02.11252024-08-07
00811687032600MCI - Medical Concept Innovation, Inc.A01.02.1107A01.02.11072024-08-07
00811687032617MCI - Medical Concept Innovation, Inc.A01.02.1110A01.02.11102024-08-07
00811687032624MCI - Medical Concept Innovation, Inc.A01.02.1127A01.02.11272024-08-07
00811687032631MCI - Medical Concept Innovation, Inc.A01.02.1109A01.02.11092024-08-07
00811687032648MCI - Medical Concept Innovation, Inc.A01.02.1103A01.02.11032024-08-07
00811687032655MCI - Medical Concept Innovation, Inc.A01.02.1106A01.02.11062024-08-07
00811687032679MCI - Medical Concept Innovation, Inc.A01.01.4022A01.01.40222024-08-07
00811687032709MCI - Medical Concept Innovation, Inc.A01.01.1153A01.01.11532024-08-07
00811687032747MCI - Medical Concept Innovation, Inc.A01.01.1145A01.01.11452024-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956281660CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
50198956281668CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
10198956244580CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
50198956244588CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
10198956251915CARDINAL HEALTHCardinal Health 200, LLCPXV2025-11-04
10198956210370CARDINAL HEALTHCardinal Health 200, LLCPXV2025-10-03
10198956137479CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
50198956137477CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
10198956057500CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
50198956057508CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
10653160383338CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONPXV2024-12-11
00843356102741CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102758CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102765CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102772CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102789CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102796CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102744CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102751CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102768CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102775CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102782CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102799CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
10197106773284CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
50197106773282CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
00843356102819CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102826CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102833CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
10653160378730CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONPXV2024-08-12
00811687031962MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08