NAVIGATED INSTRUMENTS;PHOENIX SFS

GUDID 18257200119479

MULTIAXIAL SCREW DRIVER, PHOENIX NAVIGATED MDT

ORTHOFIX INC.

Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit
Primary Device ID18257200119479
NIH Device Record Key95949832-e396-47f7-a4b9-28cc163c3fe2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNAVIGATED INSTRUMENTS;PHOENIX SFS
Version Model Number20-1219
Company DUNS927083808
Company NameORTHOFIX INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200119479 [Primary]

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


[18257200119479]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [NAVIGATED INSTRUMENTS;PHOENIX SFS]

182572001219538.5MM DILATOR SLEEVE, PHOENIX NAVIGATED
18257200121854DILATOR SLEEVE, PHOENIX NAVIGATED
182572001217938.5MM DAT SLEEVE, PHOENIX NAVIGATED
18257200121786DAT SLEEVE, PHOENIX NAVIGATED
18257200119714MULTIAXIAL SCREW DRIVER, PHOENIX NAVIGATED BL
18257200119707CANNULATED TAP, 8.5MM, PHOENIX NAVIGATED BL
18257200119691CANNULATED TAP, 7.5MM, PHOENIX NAVIGATED BL
18257200119684CANNULATED TAP, 6.5MM, PHOENIX NAVIGATED BL
18257200119677CANNULATED TAP, 5.5MM, PHOENIX NAVIGATED BL
18257200119660CANNULATED TAP, 4.5MM, PHOENIX NAVIGATED BL
18257200119479MULTIAXIAL SCREW DRIVER, PHOENIX NAVIGATED MDT
182572001194628.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT
182572001194557.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT
182572001194486.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT
182572001194315.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT
182572001194244.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT

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