FDA.reportPublic FDA data

FAICO CMF System

Primary DI
00840192714978
Brand
FAICO CMF System
Company
FAICO MEDICAL LLC
Model
F1.5-20117
Device description
Screwdriver detachable complete. Standard Head
Published
2021-04-20
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
LRZScrewdriver, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840192714978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840192714978008401927149788401927149780840192714978

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841731152121DYNEX VILEX LLCLRZ2026-05-11
00841731152183DYNEX VILEX LLCLRZ2026-05-11
00841731152282DYNEX VILEX LLCLRZ2026-05-11
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