FDA.reportPublic FDA data

FAICO CMF System

Primary DI
00840192716132
Brand
FAICO CMF System
Company
FAICO MEDICAL LLC
Model
F2.7-47000
Device description
Plate Cutting Forceps 57.5 cm
Published
2021-04-29
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
00840192716132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840192716132008401927161328401927161320840192716132

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
00198506091476ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-09
00810189451506Surgical DesignSurgical Design, Inc.GEN2026-06-06
00198506091230ELMED INCORPORATEDELMED INCORPORATEDGEN2026-06-03
G383S1061WM1413S3SURJEXSURJEXGEN2026-05-31
G383S1061WM3240913SURJEXSURJEXGEN2026-05-31
G383WM3241113SURJEXSURJEXGEN2026-05-31
00810055250929Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250936Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810055250943Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450264Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450271Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450288Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450295Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450301Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450318Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450325Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450332Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450349Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450356Surgical DesignSurgical Design, Inc.GEN2026-05-29
00810189450363Surgical DesignSurgical Design, Inc.GEN2026-05-29
G043201100BEARBear-Ent, LLCGEN2026-04-17
G043201130BEARBear-Ent, LLCGEN2026-04-17
G043201140BEARBear-Ent, LLCGEN2026-04-17
G043201160BEARBear-Ent, LLCGEN2026-04-17
G043201190BEARBear-Ent, LLCGEN2026-04-17
G043201200BEARBear-Ent, LLCGEN2026-04-17
09348811008756INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009029INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009050INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009135INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19