FDA.reportPublic FDA data

FAICO CMF System

Primary DI
00840192714350
Brand
FAICO CMF System
Company
FAICO MEDICAL LLC
Model
FRMP-1.5-6-Ang
Device description
Fracture Angulated Plate. Thickness 1.5mm. 6-holes. 9.28 mm stem
Published
2020-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840192714350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840192714350008401927143508401927143500840192714350

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate kit, non-bioabsorbableA collection of small sheets of firm material and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081290972
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840192707598FAICO CMF SystemMEDS-1.7-EC-19.0-TI-SC2020-09-18
00840192707604FAICO CMF SystemMEDS-1.7-EC-20.0-TI-SC2020-09-18
00840192707611FAICO CMF SystemMEDS-1.7-C-3.0-TI-SCD2020-09-18
00840192707628FAICO CMF SystemMEDS-1.7-C-4.0-TI-SCD2020-09-18
00840192707635FAICO CMF SystemMEDS-1.7-C-5.0-TI-SCD2020-09-18
00840192707642FAICO CMF SystemMEDS-1.7-C-6.0-TI-SCD2020-09-18
00840192707659FAICO CMF SystemMEDS-1.7-C-7.0-TI-SCD2020-09-18
00840192707666FAICO CMF SystemMEDS-1.7-C-8.0-TI-SCD2020-09-18
00840192707673FAICO CMF SystemMEDS-1.7-C-9.0-TI-SCD2020-09-18
00840192707680FAICO CMF SystemMEDS-1.7-C-10.0-TI-SCD2020-09-18
00840192707697FAICO CMF SystemMEDS-1.7-C-11.0-TI-SCD2020-09-18
00840192707703FAICO CMF SystemMEDS-1.7-C-12.0-TI-SCD2020-09-18
00840192707710FAICO CMF SystemMEDS-1.7-C-13.0-TI-SCD2020-09-18
00840192707727FAICO CMF SystemMEDS-1.7-C-14.0-TI-SCD2020-09-18
00840192707734FAICO CMF SystemMEDS-1.7-C-15.0-TI-SCD2020-09-18
00840192707741FAICO CMF SystemMEDS-1.7-C-16.0-TI-SCD2020-09-18
00840192707758FAICO CMF SystemMEDS-1.7-C-17.0-TI-SCD2020-09-19
00840192707765FAICO CMF SystemMEDS-1.7-C-18.0-TI-SCD2020-09-19
00840192707772FAICO CMF SystemMEDS-1.7-C-19.0-TI-SCD2020-09-19
00840192707789FAICO CMF SystemMEDS-1.7-C-20.0-TI-SCD2020-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118149671LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149701LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149718LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149725LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149732LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149749LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149756LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149763LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149770LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149787LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149794LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149800LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149817LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149824LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149831LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149848LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149855LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149879LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149886LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149893LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149909LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149916LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149923LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149930LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149947LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149954LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149961LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149978LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149985LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118153128LEVEL ONE NEURO, STERILEKLS-Martin L.P.JEY2026-03-23