FRAGMENT FIXATION SYSTEM W10004

GUDID 18053504365983

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

ORTHOFIX SRL

Orthopaedic implant inserter/extractor, reusable
Primary Device ID18053504365983
NIH Device Record Key39187dc3-dca5-4be5-81d5-decbac47838d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFRAGMENT FIXATION SYSTEM
Version Model Number1
Catalog NumberW10004
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

Device Identifiers

Device Issuing AgencyDevice ID
GS118053504365983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JECComponent, Traction, Invasive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18053504365983]

Moist Heat or Steam Sterilization

[18053504365983]

Moist Heat or Steam Sterilization

[18053504365983]

Moist Heat or Steam Sterilization

[18053504365983]

Moist Heat or Steam Sterilization

[18053504365983]

Moist Heat or Steam Sterilization

[18053504365983]

Moist Heat or Steam Sterilization

[18053504365983]

Moist Heat or Steam Sterilization

[18053504365983]

Moist Heat or Steam Sterilization

[18053504365983]

Moist Heat or Steam Sterilization

[18053504365983]

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 [FRAGMENT FIXATION SYSTEM]

180335098582912,5 MM THREADED WIRES (PACK OF 2)
18033509852619FFS LARGE IMPLANTS L 120/55 MM STERILE THREAD D 2.2 MM (PACK OF 4)
18033509852602FFS LARGE IMPLANTS L 120/50 MM STERILE THREAD D 2.2 MM (PACK OF 4)
18033509852596FFS LARGE IMPLANTS L 120/45 MM STERILE THREAD D 2.2 MM (PACK OF 4)
18033509852589FFS LARGE IMPLANTS L 120/40 MM STERILE THREAD D 2.2 MM (PACK OF 4)
18033509852572FFS LARGE IMPLANTS L 120/35 MM STERILE THREAD D 2.2 MM (PACK OF 4)
18033509852565FFS LARGE IMPLANTS L 120/30 MM STERILE THREAD D 2.2 MM (PACK OF 4)
18033509852558FFS LARGE IMPLANTS L 120/25 MM STERILE THREAD D 2.2 MM (PACK OF 4)
18033509852541FFS LARGE IMPLANTS L 120/20 MM STERILE THREAD D 2.2 MM (PACK OF 4)
18033509852534FFS LARGE WASHERS (PK OF 4) STERILE
18033509852527FFS MEDIUM IMPLANTS L 120/45MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852510FFS MEDIUM IMPLANTS L 120/40MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852503FFS MEDIUM IMPLANTS L 120/35MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852497FFS MEDIUM IMPLANTS L 120/30MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852480FFS MEDIUM IMPLANTS L 120/25MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852473FFS MEDIUM IMPLANTS L 120/23MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852466FFS MEDIUM IMPLANTS L 120/21MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852459FFS MEDIUM IMPLANTS L 120/19MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852442FFS MEDIUM IMPLANTS L 120/17MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852435FFS MEDIUM IMPLANTS L 120/15MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852428FFS MEDIUM IMPLANTS L 120/13MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852411FFS MEDIUM IMPLANTS L 120/11MM STERILE THREAD D 1.6 MM (PACK OF 4)
18033509852404FFS MEDIUM WASHERS (PK OF 4) STERILE
18033509852398FFS SMALL IMPLANTS L 120/21 MM STERILE THREAD D 1.2 MM (PACK OF 4)
18033509852381FFS SMALL IMPLANTS L 120/19 MM STERILE THREAD D 1.2 MM (PACK OF 4)
18033509852374FFS SMALL IMPLANTS L 120/17 MM STERILE THREAD D 1.2 MM (PACK OF 4)
18033509852367FFS SMALL IMPLANTS L 120/15 MM STERILE THREAD D 1.2 MM (PACK OF 4)
18033509852350FFS SMALL IMPLANTS L 120/13 MM STERILE THREAD D 1.2 MM (PACK OF 4)
18033509852343FFS SMALL IMPLANTS L 120/11 MM STERILE THREAD D 1.2 MM (PACK OF 4)
18033509852336FFS SMALL IMPLANTS L 120/9 MM STERILE THREAD D 1.2 MM (PACK OF 4)
18033509852329FFS SMALL IMPLANTS L 120/7 MM STERILE THREAD D 1.2 MM (PACK OF 4)
18032568866605CEPHALIC BONE SCREW END CAP
18032568866407OSTEOTITE CEPHALIC BONE SCREW 120/30 MM STERILE
18032568866391OSTEOTITE CEPHALIC BONE SCREW 110/30 MM STERILE
18032568866360CANNULATED CEPHALIC BONE SCREW 120/30 MM
18032568866353CANNULATED CEPHALIC BONE SCREW 110/25 MM
18032568865615FFS LARGE IMPLANTS L 120/55 MM THREAD D 2.2 MM (PACK OF 4)
18032568865608FFS LARGE IMPLANTS L 120/50 MM THREAD D 2.2 MM (PACK OF 4)
18032568865592FFS LARGE IMPLANTS L 120/45 MM THREAD D 2.2 MM (PACK OF 4)
18032568865585FFS LARGE IMPLANTS L 120/40 MM THREAD D 2.2 MM (PACK OF 4)
18032568865578FFS LARGE IMPLANTS L 120/35 MM THREAD D 2.2 MM (PACK OF 4)
18032568865561FFS LARGE IMPLANTS L 120/30 MM THREAD D 2.2 MM (PACK OF 4)
18032568865554FFS LARGE IMPLANTS L 120/25 MM THREAD D 2.2 MM (PACK OF 4)
18032568865547FFS LARGE IMPLANTS L 120/20 MM THREAD D 2.2 MM (PACK OF 4)
18032568865530FFS LARGE IMPLANTS STERI BOX EMPTY
18032568865523FFS LARGE WASHERS (PK OF 4)
18032568865516FFS MEDIUM IMPLANTS L 120/45MM THREAD D 1.6 MM (PACK OF 4)
18032568865509FFS MEDIUM IMPLANTS L 120/40MM THREAD D 1.6 MM (PACK OF 4)
18032568865493FFS MEDIUM IMPLANTS L 120/35MM THREAD D 1.6 MM (PACK OF 4)
18032568865486FFS MEDIUM IMPLANTS L 120/30MM THREAD D 1.6 MM (PACK OF 4)
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