GALAXY FIXATION GEMINI 99-94760

GUDID 18053340348850

GALAXY FIXATION GEMINI QUADRILATERAL SET COMPLETE STERILE

ORTHOFIX SRL

External orthopaedic fixation system, single-use
Primary Device ID18053340348850
NIH Device Record Keyb052836e-e7f5-4800-9276-52043f15eadd
Commercial Distribution StatusIn Commercial Distribution
Brand NameGALAXY FIXATION GEMINI
Version Model Number1
Catalog Number99-94760
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS118053340348850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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