| Primary Device ID | 18257200131440 |
| NIH Device Record Key | fbbef4cb-363c-4ae6-83a8-f345efca6772 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEMF - CERVICAL-STIM |
| Version Model Number | 655505-7001 |
| Catalog Number | COMFORT COLLAR, CERV STIM |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200131440 [Primary] |
| LOF | Stimulator, bone growth, non-invasive |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
Moist Heat or Steam Sterilization
[18257200131440]
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 |
| 18257200131440 | COMFORT COLLAR, CERVICAL STIM 5505, ACCESSORY |
| 18257200123933 | 5505CMD, DEMO, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, CM |
| 18257200123919 | 5505CM, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, CM |
| 18257200105663 | 5505CED, DEMO, OSTEOGENESIS STIMULATOR, CERVICAL-STIM, OUS |
| 18257200105656 | 5505CE, SHIP ASSY., OSTEOGENESIS STIMULATOR, CERVICAL-STIM, OUS |