GALAXY FIXATION GEMINI 94300

GUDID 18053340348768

GALAXY FIXATION GEMINI UNIVERSAL MULTIPIN CLAMP

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18053340348768
NIH Device Record Key0461d35e-0189-4bf4-8598-7d51cb792b2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGALAXY FIXATION GEMINI
Version Model Number1
Catalog Number94300
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it
Phone+390456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118053340348768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


[18053340348768]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-04
Device Publish Date2021-12-27

On-Brand Devices [GALAXY FIXATION GEMINI]

18053340348898GALAXY FIXATION GEMINI STERILIZATION TRAY LAYER
18053340348881GALAXY FIXATION GEMINI STERILIZATION TRAY BASE
18053340348874GALAXY FIXATION GEMINI STERILIZATION TRAY LID
18053340348867GALAXY FIXATION GEMINI STERILIZATION TRAY EMPTY
18053340348850GALAXY FIXATION GEMINI QUADRILATERAL SET COMPLETE STERILE
18053340348843GALAXY FIXATION GEMINI METATARSAL SET COMPLETE STERILE
18053340348836GALAXY FIXATION GEMINI ANKLE 4MM SET COMPLETE STERILE
18053340348829GALAXY FIXATION GEMINI ANKLE 6MM SET COMPLETE STERILE
18053340348812GALAXY FIXATION GEMINI Z FRAME SET COMPLETE STERILE
18053340348805GALAXY FIXATION GEMINI PELVIS SET COMPLETE STERILE
18053340348775GALAXY FIXATION GEMINI MULTIPIN CLAMP STERILE
18053340348768GALAXY FIXATION GEMINI UNIVERSAL MULTIPIN CLAMP
18053340348751GALAXY FIXATION GEMINI DOUBLE MULTIPIN CLAMP MEDIUM STERILE
18053340348744GALAXY FIXATION GEMINI DOUBLE MULTIPIN CLAMP STERILE
18053340348737GALAXY FIXATION GEMINI DOUBLE UNIVERSAL MULTIPIN CLAMP
18053340348720GALAXY FIXATION GEMINI TRANSITIONAL SINGLE CLAMP STERILE
18053340348713GALAXY FIXATION GEMINI SINGLE CLAMP STERILE
18053340348706GALAXY FIXATION GEMINI UNIVERSAL SINGLE CLAMP
18052469472583GALAXY FIXATION GEMINI SCREW GUIDE
18052469472576GALAXY FIXATION GEMINI TROCAR

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