PEMF - CERVICAL-STIM 5505CED

GUDID 18257200105663

5505CED, DEMO, OSTEOGENESIS STIMULATOR, CERVICAL-STIM, OUS

ORTHOFIX INC.

Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope
Primary Device ID18257200105663
NIH Device Record Keyb77e108c-c073-46a4-a590-fc8e74ad4f5d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEMF - CERVICAL-STIM
Version Model Number655505-0004
Catalog Number5505CED
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 Usefalse
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
GS118257200105663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOFStimulator, bone growth, non-invasive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


[18257200105663]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-07
Device Publish Date2020-01-30

On-Brand Devices [PEMF - CERVICAL-STIM]

18257200131440COMFORT COLLAR, CERVICAL STIM 5505, ACCESSORY
182572001239335505CMD, DEMO, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, CM
182572001239195505CM, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, CM
182572001056635505CED, DEMO, OSTEOGENESIS STIMULATOR, CERVICAL-STIM, OUS
182572001056565505CE, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, OUS

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