| Primary Device ID | 18257200135936 |
| NIH Device Record Key | 77fb03a8-a65b-46c0-b606-082a8cf26014 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEMF - PHYSIO-STIM |
| Version Model Number | 655314-0104 |
| Catalog Number | 5314RCED |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200135936 [Primary] |
| LOF | Stimulator, bone growth, non-invasive |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
[18257200135936]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-07 |
| Device Publish Date | 2020-01-30 |
| 18257200132010 | 5315, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200132003 | 5314R, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200131990 | 5314L, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200131983 | 5313, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200131976 | 5303, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200131969 | 5302, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200136001 | 5315CMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135998 | 5315CED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135981 | 5315D, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200135974 | 5314LCMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135967 | 5314LCED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135950 | 5314LD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200135943 | 5314RCMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135936 | 5314RCED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135929 | 5314RD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200135912 | 5313CMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135905 | 5313CED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135899 | 5313D, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200135882 | 5302CMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135875 | 5302CED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135868 | 5302D, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US |
| 18257200135790 | REPLACEMENT STRAP, PHYSIOSTIM 5315XX, ACCESSORY |
| 18257200135783 | SHORT STRAP, PHYSIOSTIM 5313XX, ACCESSORY |
| 18257200135776 | REPLACEMENT STRAP, PHYSIOSTIM 5313XX/5314XXX, ACCESSORY |
| 18257200135769 | REPLACEMENT STRAP, PHYSIOSTIM 5302XX/5303XX, ACCESSORY |
| 18257200135738 | 5314RCM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135721 | 5314RCE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135714 | 5315CM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135707 | 5315CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135691 | 5314LCM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135684 | 5314LCE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135677 | 5313CM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135660 | 5313CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135653 | 5303CM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135646 | 5303CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200135639 | 5302CM, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CM |
| 18257200135622 | 5302CE, SHIP ASSY., BONE GROWTH STIMULATOR, PHYSIOSTIM, CE |
| 18257200134199 | SURE FIT CUSHION, PHYSIO STIM 5303, ACCESSORY |
| 18257200134182 | SURE FIT CUSHION, PHYSIO STIM 5302, ACCESSORY |