FDA.reportPublic FDA data

MCI - Medical Concept Innovation, Inc.

Primary DI
00811687032440
Brand
MCI - Medical Concept Innovation, Inc.
Company
MCI-MEDICAL CONCEPT INNOVATION INC
Model
A02.01.1511
Catalog number
A02.01.1511
Device description
CMF ORTHOGNATHIC 1.5
Published
2024-08-08
Public version status
New
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
00811687032440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811687032440008116870324408116870324400811687032440

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
954-306-2521customer.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
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
00811687031962MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032457MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032464MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08