HYBRID FIXATOR SYSTEM 80041

GUDID 18032568860382

INDEPENDENT WIRE CLAMP

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18032568860382
NIH Device Record Keyb347e4d1-c23c-4f25-8b1c-a1517dfb92b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYBRID FIXATOR SYSTEM
Version Model Number1
Catalog Number80041
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

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568860382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JECComponent, Traction, Invasive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568860382]

Moist Heat or Steam Sterilization


[18032568860382]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-19

On-Brand Devices [HYBRID FIXATOR SYSTEM]

18033509851766X-WIRE WITHOUT OLIVE STERILE DIAMETER 1,8 MM LENGTH 400 MM
18033509851759X-WIRE WITH CENTRAL OLIVE STERILE DIAMETER 1,8 MM LENGTH 400 MM
18033509851742X-WIRE WITHOUT OLIVE STERILE DIAMETER 2 MM LENGTH 450 MM
18033509851735X-WIRE WITH CENTRAL OLIVE STERILE DIAMETER 2 MM LENGTH 450 MM
18033509851728X-WIRE WITHOUT OLIVE STERILE DIAMETER 2 MM LENGTH 400 MM
18033509851711X-WIRE WITH CENTRAL OLIVE STERILE DIAMETER 2 MM LENGTH 400 MM
18033509851704X-WIRE WITH LATERAL OLIVE STERILE DIAMETER 2 MM LENGTH 400 MM
18033509851698X-WIRE WITH LATERAL OLIVE STERILE DIAMETER 2 MM LENGTH 350 MM
18033509851681X-WIRE WITH LATERAL OLIVE STERILE DIAMETER 2 MM LENGTH 310 MM
18032568869217X-WIRE WITHOUT OLIVE DIAMETER 1,8 MM LENGTH 400 MM
18032568869200X-WIRE WITH CENTRAL OLIVE DIAMETER 1,8 MM LENGTH 400 MM
18032568860955HYBRID SYSTEM STERI BOX EMPTY
18032568860948HYBRID SYSTEM STERI BOX EMPTY
18032568860832SUPPLEMENTARY SCREW HOLDER BAR RADIOLUCENT 300 MM
18032568860597WIRE COVERS (PACK OF 20)
18032568860580X-WIRE WITHOUT OLIVE DIAMETER 2 MM LENGTH 450 MM
18032568860573X-WIRE WITH CENTRAL OLIVE DIAMETER 2 MM LENGTH 450 MM
18032568860566X-WIRE WITHOUT OLIVE DIAMETER 2 MM LENGTH 400 MM
18032568860559X-WIRE WITH CENTRAL OLIVE DIAMETER 2 MM LENGTH 400 MM
18032568860542X-WIRE WITH LATERAL OLIVE DIAMETER 2 MM LENGTH 400 MM
18032568860535X-WIRE WITH LATERAL OLIVE DIAMETER 2 MM LENGTH 350 MM
18032568860528X-WIRE WITH LATERAL OLIVE DIAMETER 2 MM LENGTH 310 MM
18032568860474ASSEMBLY KIT SHORT FOR HYBRID PROCALLUS
18032568860467ASSEMBLY KIT STANDARD FOR HYBRID PROCALLUS
18032568860450HYBRID COUPLING WITH BALL-JOINT
18032568860436POST LENGTH 150 MM
18032568860412POST LENGTH 100 MM
18032568860405SUPPLEMENTARY SCREW HOLDER BAR DIAMETER 6 MM LENGTH 300 MM
18032568860399POST LENGTH 50 MM
18032568860382INDEPENDENT WIRE CLAMP
180325688602903-HOLE WIRE CLAMP SLIDER UNIT
18032568860276TWO-HOLE K-WIRE SECURING PIN
18032568035193HYBRID COUPLING TEMPLATE WITH BALL-JOINT (10000 SERIES)
18032568035186WIRE GUIDE
18032568035179WIRE TENSIONER
18053504366188Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504365778Component. Not for sale. Used for reporting Direct Marking of assembly.

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