FDA.reportPublic FDA data

FAICO CMF System

Primary DI
00840192714756
Brand
FAICO CMF System
Company
FAICO MEDICAL LLC
Model
F1.2-40018
Device description
CUSHING Plate-Screw holding forcep 17.5 cm. Straight
Published
2021-04-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840192714756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840192714756008401927147568401927147560840192714756

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

Regulatory Flags#

DUNS number
081290972
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840192709073FAICO CMF SystemMEDP-0.6-6-Q2020-09-20
00840192709080FAICO CMF SystemMEDP-0.6-8-Q2020-09-20
00840192709097FAICO CMF SystemMEDP-0.6-16-Q2020-09-20
00840192709103FAICO CMF SystemMEDP-0.6-24-Q2020-09-20
00840192709110FAICO CMF SystemMEDP-0.6-4-RC2020-09-20
00840192709127FAICO CMF SystemMEDP-0.6-6-RC2020-09-20
00840192709134FAICO CMF SystemMEDP-0.6-8-RC2020-09-20
00840192709141FAICO CMF SystemMEDP-0.6-16-RC2020-09-20
00840192709158FAICO CMF SystemMEDP-0.6-24-RC2020-09-20
00840192709165FAICO CMF SystemMEDP-0.6-6-NG-S2020-09-20
00840192709172FAICO CMF SystemMEDP-0.6-6-NG-M2020-09-20
00840192709189FAICO CMF SystemMEDP-0.6-6-NG-L2020-09-20
00840192709196FAICO CMF SystemMEDP-0.6-8-NST-S2020-09-20
00840192709202FAICO CMF SystemMEDP-0.6-8-NST-L2020-09-20
00840192709219FAICO CMF SystemMEDMESH-0.3-80x502020-09-20
00840192709226FAICO CMF SystemMEDMESH-0.6-80x502020-09-20
00840192709233FAICO CMF SystemMEDP-0.6-0-Lfort-L2020-09-20
00840192709240FAICO CMF SystemMEDP-0.6-2-Lfort-L2020-09-20
00840192709257FAICO CMF SystemMEDP-0.6-3-Lfort-L2020-09-20
00840192709264FAICO CMF SystemMEDP-0.6-4-Lfort-L2020-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776402112MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776402136MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776400255MillenniumAvalign Technologies, Inc.GEN2026-07-17
B382SD9013461020Surgical DirectSurgical Direct, Inc.GEN2026-07-17
00190776397050MillenniumAvalign Technologies, Inc.GEN2026-07-16
00190776398651MillenniumAvalign Technologies, Inc.GEN2026-07-16
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275495Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275600Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275723Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275846Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275938Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275976Intrace USAPILOTIS TECH LLCGEN2026-07-03
00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00190776421656MillenniumAvalign Technologies, Inc.GEN2026-06-23
00810055258512Surgical DesignSurgical Design, Inc.GEN2026-06-22