PELVIC FIXATOR 10087

GUDID 18032568030860

PRIMARY LINK

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18032568030860
NIH Device Record Key0532de6c-4b75-4add-814a-403cd60150d1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePELVIC FIXATOR
Version Model Number1
Catalog Number10087
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
GS118032568030860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568030860]

Moist Heat or Steam Sterilization


[18032568030860]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

On-Brand Devices [PELVIC FIXATOR]

18032568032833PELVIC FIXATOR STERI BOX EMPTY
18032568030884CONNECTING UNIT FOR PELVIC FIXATOR
18032568030877SUPPLEMENTARY LINK FOR PELVIC FIXATOR
18032568030860PRIMARY LINK
18032568030853PELVIC FIXATOR SHORT BODY
18032568030846PELVIC FIXATOR LONG BODY
18032568030839PELVIC FIXATOR LONG KIT WITH INDEP.SCREW PLACEMENT MODULES
18032568030822PELVIC FIXATOR SHORT MODEL KIT
18032568030815PELVIC FIXATOR LONG MODEL KIT
18032568030655INDEPENDENT SCREW CLAMP
18032568030648BALL-JOINTED MODULE FOR INDEPENDENT SCREW PLACEMENT
18053504364856Component. Not for sale. Used for reporting Direct Marking of assembly.
18053504364832Component. Not for sale. Used for reporting Direct Marking of assembly.

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