Spinal-Stim
GUDID 18257200078929
Spinal-Stim Bone Growth Stimulator
ORTHOFIX INC.
Patient-worn bone growth electromagnetic stimulator| Primary Device ID | 18257200078929 |
| NIH Device Record Key | ac605d8e-b6c9-4936-8334-ad766436c79a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spinal-Stim |
| Version Model Number | 2212 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200078929 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P850007
FDA Product Code
| LOF | Stimulator, bone growth, non-invasive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [Spinal-Stim]
| 18257200079124 | Spinal-Stim Bone Growth Stimulator |
| 18257200078929 | Spinal-Stim Bone Growth Stimulator |
| 18257200007127 | Spinal-Stim Bone Growth Stimulator |
| 18257200007110 | Spinal-Stim Bone Growth Stimulator |
Trademark Results [Spinal-Stim]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPINAL-STIM 73552537 1384143 Live/Registered |
AMERICAN MEDICAL ELECTRONICS, INC. 1985-08-08 |
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