MJ-FLEX 166383

GUDID 18054242518785

NAIL IMPACTOR - 4/5

ORTHOFIX SRL

Orthopaedic implant impactor
Primary Device ID18054242518785
NIH Device Record Keyd7c29792-9d88-4a7c-81cd-0bf10424be3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMJ-FLEX
Version Model Number1
Catalog Number166383
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Dimensions

Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter
Width51 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118054242518785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

[18054242518785]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-28

On-Brand Devices [MJ-FLEX]

18054242518921MJ-FLEX SS NAIL L450MM D5MM STERILE
18054242518914MJ-FLEX SS NAIL L450MM D4.5MM STERILE
18054242518907MJ-FLEX SS NAIL L450MM D4MM STERILE
18054242518891MJ-FLEX TI NAIL L450MM D5MM STERILE
18054242518884MJ-FLEX TI NAIL L450MM D4.5MM STERILE
18054242518877MJ-FLEX TI NAIL L450MM D4MM STERILE
18054242518860MJ-FLEX TI NAIL L400MM D3.5MM STERILE
18054242518853MJ-FLEX TI NAIL L400MM D3MM STERILE
18054242518846MJ-FLEX TI NAIL L400MM D2.5MM STERILE
18054242518839STERILIZATION BOX COMPLETE
18054242518822STERILIZATION BOX EMPTY
18054242518815HAMMER
18054242518808SLAP HAMMER
18054242518792EXTRACTION PLIERS
18054242518785NAIL IMPACTOR - 4/5
18054242518778NAIL IMPACTOR - 2/3
18054242518761NAIL CUTTER
18054242518754NAIL INSERTER
18054242518747BENDER - LEFT
18054242518730BENDER - RIGHT
18054242518723BONE AWL
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