MINIRAIL SYSTEM M101

GUDID 18032568866636

MINIRAIL, STANDARD, LENGTHENER

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18032568866636
NIH Device Record Keyd0ac7c99-5ed8-4f59-944d-e26f003aad8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMINIRAIL SYSTEM
Version Model Number1
Catalog NumberM101
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 Identifiers

Device Issuing AgencyDevice ID
GS118032568866636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

Moist Heat or Steam Sterilization

[18032568866636]

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 [MINIRAIL SYSTEM]

18032568869996MINIRAIL, SHORT
18032568869965SPECIAL MINIRAIL SHORT LENGHTNER
18032568866872SCREW FORCEPS
18032568866865T-WRENCH FOR BONE SCREWS
18032568866834MINIRAIL SYSTEM STERI BOX EMPTY
18032568866810CALCANEUM FIXATOR
18032568866803MINIRAIL LENGTHENER & FIXATOR CLAMP COVER
18032568866773PLATE LOCKING SCREW
18032568866766BALL JOINT T-CLAMP (M130)
18032568866742MINIRAIL LENGTHENER & FIXATOR CLAMP COVER SCREW
18032568866735CLAMP COVER (MINI)
18032568866711MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS
18032568866681ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS
18032568866667MINIRAIL, LENGTHENER, T-CLAMP
18032568866650MINIRAIL, SHORT, LENGTHENER
18032568866643MINIRAIL LONG LENGTHENER
18032568866636MINIRAIL, STANDARD, LENGTHENER
18032568866551ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS - DOUBLE SLIDE
18032568866544M2 MULTIPLANAR MINIRAIL
18032568866520DRIVER FOR 3MM SHAFT SCREWS
18032568866513MINI RAIL, NON-SWIVEL, CLAMP COVER
18032568865073MINISANDWICH CLAMP KIT
18032568865059MICROMETRIC ARTICULATED MINIRAIL FIXATOR HORIZ.AXIS
18032568865042ARTICULATED MINIRAIL FIXATOR WITH HINGE
18032568865028MINILENGTHENER TRIPLE CLAMPS
18032568864465BILATERAL MINILENGTHENER L.173 MM
18032568864458BILATERAL MINILENGTHENER L.145 MM
18032568864441BILATERAL MINILENGTHENER L.110 MM
18032568864434BILATERAL MINILENGTHENER L.85 MM
18032568039757CALCANEAL MINIFIXATOR KIT STERILE
18032568039696CALCANEAL TEMPLATE KIT
18032568039313CALCANEAL MINIFIXATOR
18032568039221MINIRAIL TEMPLATE KIT, PKG OF 4
18053504366409Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504366393Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504366386Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504366379Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504366362Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504365716Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504365709Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
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