Orthofix Osteogenesis Stimulator 652212-0017

GUDID 18257200080793

Spinal-Stim Osteogenesis Stimulator

ORTHOFIX INC.

Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator Patient-worn bone growth electromagnetic stimulator
Primary Device ID18257200080793
NIH Device Record Keyf3b7ab3f-d2c1-4cd6-8caf-b3d3c5c52b58
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthofix Osteogenesis Stimulator
Version Model Number2212
Catalog Number652212-0017
Company DUNS927083808
Company NameORTHOFIX INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.c
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.c
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com
Phone+1(214)937-2718
Emailpemfcustomerservice@orthofix.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200080793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOFStimulator, bone growth, non-invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-05-12

On-Brand Devices [Orthofix Osteogenesis Stimulator]

18257200080823Cervical-Stim Osteogenesis Stimulator, Demo
18257200080816Cervical-Stim Osteogenesis Stimulator
18257200080809Spinal-Stim Osteogensis Stimulator, Demo
18257200080793Spinal-Stim Osteogenesis Stimulator
18257200080786Physio-Stim Osteogenesis Stimulator, Demo
18257200080779Physio-Stim Osteogenesis Stimulator
18257200080762Physio-Stim Osteogensis Stimulator, Demo
18257200080755Physio-Stim Osteogenesis Stimulator
18257200080748Physio-Stim Osteogenesis Stimulator, Demo
18257200080731Physio-Stim Osteogenesis Stimulator
18257200080724Physio-Stim Osteogensis Stimulator, Demo
18257200080717Physio-Stim Osteogenesis Stimulator
18257200080700Physio-Stim Osteogenesis Stimulator, Demo
18257200080694Physio-Stim Osteogenesis Stimulator
18257200080687Physio-Stim Osteogenesis Stimulator, Demo
18257200080670Physio-Stim Osteogenesis Stimulator

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