PENNIG MINIFIXATOR 600350

GUDID 18053504367765

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

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18053504367765
NIH Device Record Keyceb11b01-9ef6-4695-8978-b436308c3688
Commercial Distribution StatusIn Commercial Distribution
Brand NamePENNIG MINIFIXATOR
Version Model Number1
Catalog Number600350
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

Device Identifiers

Device Issuing AgencyDevice ID
GS118053504367765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18053504367765]

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 [PENNIG MINIFIXATOR]

18033509851926PMF THREADED WIRES D 2.0 MM STERILE LENGTH 100/15 MM (PACK OF 4)
18033509851919PMF THREADED WIRES D 1.6 MM STERILE LENGTH 70/15 MM (PACK OF 4)
18032568867190PENNIG MINIFIXATOR STERI BOX EMPTY
18032568867183THREADED, WIRE EXTRACTOR
18032568867176REDUCTION FORCEPS (2 PAIRS) FOR PENNIG MINIFIXATOR
18032568867169PMF, THREADED WIRES, D 2.0 MM LENGTH 100/15 MM (PACK OF 4)
18032568867152PMF, THREADED WIRES, D 1.6 MM LENGTH 70/15 MM (PACK OF 4)
18032568867145PENNIG MINIFIXATOR SPACER
18032568867138LENGTHENING BAR, LONG, 120 MM FOR PENNIG MINIFIXATOR
18032568867121LENGTHENING BAR, STD, 100 MM FOR PENNIG MINIFIXATOR
18032568867114LENGTHENING BAR, SHORT, 80 MM FOR PENNIG MINIFIXATOR
18032568867091CLAMP, LOCKING SCREW FOR PENNIG MINIFIXATOR
18032568867084NUT, COMPRESSION/DISTRACTION
18032568867077CLAMPS, STANDARD, (ONE PAIR) FOR PENNIG MINIFIXATOR
18032568867060L-CLAMPS (LEFT/RIGHT SET) FOR PENNIG MINIFIXATOR
18032568867053PMF, EXTRA LONG BODY
18032568867046PENNIG MINIFIXATOR LONG KIT
18032568867039PENNIG MINIFIXATOR STD KIT
18032568867022PENNIG MINIFIXATOR SHORT KIT
18032568867015PENNIG MINIFIXATOR LONG BODY
18032568867008PENNIG MINIFIXATOR, STD, BODY
18032568866995PENNIG MINIFIXATOR, SHORT, BODY
18032568866346MINI PENNIG ARTICULATED BODY
18032568865011PMF, 3MM SCREW CLAMP (PAIR)
18032568865004PMF LENGTHENING BAR 150 MM
18053504367765Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

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