SHEFFIELD RING FIXATOR 815925

GUDID 18053504365969

Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18053504365969
NIH Device Record Keyc17c9002-cc83-43e6-85de-9e43392f4e23
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHEFFIELD RING FIXATOR
Version Model Number1
Catalog Number815925
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

Device Identifiers

Device Issuing AgencyDevice ID
GS118053504365969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JECComponent, Traction, Invasive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

[18053504365969]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-29
Device Publish Date2019-04-19

On-Brand Devices [SHEFFIELD RING FIXATOR ]

18033509856570K-WIRE LOSS OF TENSION ESTIMATION ACCESSORY
180335098562283-HOLE POST, 90 DEGREES
180335098562112-HOLE POST, 90 DEGREES
18033509856112POST CLAMP
18033509855412K-WIRE LOCKING SCREW (PACK OF 2)
18032937169610MAGIC CUBE
18032937168071HALF PIN BOLT
18032568867275HYBRID RINGS STERIBOX, EMPTY
180325688665062 HOLE K-WIRE CLAMP
180325688664904 HOLE K-WIRE CLAMP
18032568866483K.WIRE CLAMP KIT
18032568865714CHONDRODIATASI HYBRID KIT RING D.150 MM
180325688648542/3 RING DIA. 240 MM
18032568860979FOOT RING DIAMETER 150 MM
18032568860962SHEFFIELD RING FIXATION SYSTEM STERI BOX EMPTY
180325688608701/3 RING MM 125
180325688608632/3 RING INNER DIAMETER 125MM
18032568860856THREADED BARS LENGTH 400MM (SET OF 3)
18032568860849THREADED BARS LENGTH 300MM (SET OF 3)
18032568860825THREADED BARS LENGTH 200MM (SET OF 3)
18032568860818THREADED BARS LENGTH 160MM (SET OF 3)
18032568860801THREADED BARS LENGTH 120MM (SET OF 3)
18032568860795THREADED BARS LENGTH 80MM (SET OF 3)
18032568860788OPEN END WRENCH
18032568860771SPEED WRENCH
18032568860764COUNTER NUT
18032568860757BOLT 25 MM (PACK OF 10)
18032568860740SLOTTED WASHERS (PACK OF 10)
18032568860733NUTS & WASHERS (PACK OF 20)
18032568860726BOLT 35 MM (PACK OF 10)
18032568860719EXTENSION PLATE
18032568860702HINGE CLAMP
18032568860696TRANSLATION ROTATION HINGE
18032568860689RING LOCKING SCREW
180325688606721/3 RING INNER DIAMETER 220MM
180325688606652/3 RING INNER DIAMETER 220MM
180325688606581/3 RING INNER DIAMETER 190MM
180325688606412/3 RING INNER DIAMETER 190MM
180325688606341/3 RING INNER DIAMETER 175MM
180325688606272/3 RING INNER DIAMETER 175MM
180325688606101/3 RING INNER DIAMETER 150MM
180325688606032/3 RING INNER DIAMETER 150MM
180325688605118/10 MM SPANNER
18032568860504SINGLE SCREW CLAMP
18032568860443REDUCTION UNIT
18032568860368THREADED BARS LENGTH 200 MM (SET OF 3)
18032568860351THREADED BARS LENGTH 160 MM (SET OF 3)
18032568860344THREADED BARS LENGTH 120 MM (SET OF 3)
18032568860337THREADED BARS LENGTH 80 MM (SET OF 3)
18032568860313SHEFFIELD CLAMP
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