PEMF - PHYSIO-STIM 5315CMD

GUDID 18257200136001

5315CMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM

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 ID18257200136001
NIH Device Record Key83757c9c-2303-42fe-a9f6-db4cd533c95b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEMF - PHYSIO-STIM
Version Model Number655315-0006
Catalog Number5315CMD
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
GS118257200136001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOFStimulator, bone growth, non-invasive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

Moist Heat or Steam Sterilization


[18257200136001]

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 - PHYSIO-STIM]

182572001320105315, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001320035314R, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001319905314L, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001319835313, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001319765303, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001319695302, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001360015315CMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001359985315CED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001359815315D, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001359745314LCMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001359675314LCED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001359505314LD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001359435314RCMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001359365314RCED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001359295314RD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001359125313CMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001359055313CED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001358995313D, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US
182572001358825302CMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001358755302CED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001358685302D, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US
18257200135790REPLACEMENT STRAP, PHYSIOSTIM 5315XX, ACCESSORY
18257200135783SHORT STRAP, PHYSIOSTIM 5313XX, ACCESSORY
18257200135776REPLACEMENT STRAP, PHYSIOSTIM 5313XX/5314XXX, ACCESSORY
18257200135769REPLACEMENT STRAP, PHYSIOSTIM 5302XX/5303XX, ACCESSORY
182572001357385314RCM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001357215314RCE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001357145315CM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001357075315CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001356915314LCM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001356845314LCE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001356775313CM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001356605313CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001356535303CM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001356465303CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
182572001356395302CM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
182572001356225302CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
18257200134199SURE FIT CUSHION, PHYSIO STIM 5303, ACCESSORY
18257200134182SURE FIT CUSHION, PHYSIO STIM 5302, ACCESSORY

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