FDA.reportPublic FDA data

FAICO CMF System

Primary DI
00840192715357
Brand
FAICO CMF System
Company
FAICO MEDICAL LLC
Model
FL2.0-11005
Device description
Spiral-Drill with Sk-connection, D.1.1 mm. 5 mm stop. 45 mm
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
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840192715357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840192715357008401927153578401927153570840192715357

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
DM exempt
false
Premarket exempt
true
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

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Primary DI, Brand, Company table
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04048844358839MUTARS®implantcast GmbHHTW2026-03-24
00840314270245gSourceGSOURCE LLCHTW2026-03-20
00840314270252gSourceGSOURCE LLCHTW2026-03-20
00840314270269gSourceGSOURCE LLCHTW2026-03-20
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06974940307007endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307021endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
06974940307038endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
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00810056993122corraCarlsmed, Inc.HTW2026-01-30
00810056993153corraCarlsmed, Inc.HTW2026-01-30
00810056993160corraCarlsmed, Inc.HTW2026-01-30