FDA.reportPublic FDA data

MCI - Medical Concept Innovation, Inc.

Primary DI
00811687031122
Brand
MCI - Medical Concept Innovation, Inc.
Company
MCI-MEDICAL CONCEPT INNOVATION INC
Model
A02.01.1412
Catalog number
A02.01.1412
Device description
PLATE HOLDER FORCEPS 1.5 - 2.0
Published
2023-06-16
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811687031122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811687031122008116870311228116870311220811687031122

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

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