EBI OsteoGen Implantable Bone Growth Stimulator
- Primary DI
- 00812301020010
- Brand
- EBI OsteoGen Implantable Bone Growth Stimulator
- Company
- EBI, LLC
- Model
- 10-1318
- Catalog number
- 10-1318
- Device description
- OSteoGen 20/F
- Published
- 2014-09-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
Code, Name table| Code | Name |
|---|
| LOE | Stimulator, Invasive Bone Growth |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| LOE | Stimulator, Invasive Bone Growth | Unknown | 3 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00812301020010 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
Source identifier, GTIN-14 normalized, UPC-A table| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00812301020010 | 00812301020010 | 812301020010 | 0812301020010 |
Storage And Handling#
Type, Low, High table| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 41 Degrees Fahrenheit | 77 Degrees Fahrenheit | |
Regulatory Flags#
- DUNS number
- 050410323
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
Primary DI, Brand, Model table| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00888480588528 | Reficio DBM Paste | 20700221 | | 2015-10-19 |
| 00888480588535 | Reficio DBM Paste | 20700321 | | 2015-10-19 |
| 00888480588542 | Reficio DBM Paste | 20700421 | | 2015-10-19 |
| 00888480588559 | Reficio DBM Plus | 20800521 | | 2015-10-19 |
| 00888480588566 | Reficio DBM Plus | 20900321 | | 2015-10-19 |
| 00888480588573 | Reficio DBM Plus | 20900421 | | 2015-10-19 |
| 00888480588580 | Reficio DBM Plus | 20900521 | | 2015-10-19 |
| 00880304820852 | Biomet SpinalPak / OrthoPak | 106130-22 | 106130-22 | 2016-06-07 |
| 00812301020188 | Biomet SpinalPak / OrthoPak | 106130-12 | 106130-12 | 2014-09-19 |
| 00812301020201 | Biomet SpinalPak / OrthoPak | 106130-20 | 106130-20 | 2014-09-19 |
| 00812301020515 | Biomet EBI Bone Healing System | 1068226 | 1068226 | 2014-09-19 |
| 00887868269264 | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System | 1067716-45 | 1067716-45 | 2019-02-28 |
| 00887868269271 | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System | 1067716-63 | 1067716-63 | 2019-02-28 |
| 00887868269288 | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System | 1067716-72 | 1067716-72 | 2019-02-28 |
| 00887868269295 | Biomet OrthoPak Non-invasive Bone Growth Stimulator System | 1067718-45 | 1067718-45 | 2019-02-28 |
| 00887868269301 | Biomet OrthoPak Non-invasive Bone Growth Stimulator System | 1067718-63 | 1067718-63 | 2019-02-28 |
| 00887868269318 | Biomet OrthoPak Non-invasive Bone Growth Stimulator System | 1067718-72 | 1067718-72 | 2019-02-28 |
| 00880304820845 | Biomet SpinalPak / OrthoPak | 106130-14 | 106130-14 | 2016-06-07 |
| 00812301020027 | EBI OsteoGen™ Implantable Bone Growth Stimulator | 10-1320 | 10-1320 | 2014-09-19 |
| 00812301020034 | EBI OsteoGen™ Implantable Bone Growth Stimulator | 10-1320M | 10-1320M | 2014-09-19 |
Other Devices Sharing Product Codes#
Primary DI, Brand, Company table| Primary DI | Brand | Company | Product code | Published |
|---|
| 00812301020027 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020034 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020041 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020058 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020065 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020072 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020089 | SpF XL IIb Implantable Spinal Fusion Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020096 | SpF®-XL IIb Implantable Spinal Fusion Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020102 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020119 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | LOE | 2014-09-19 |
| 00812301020126 | SpF®-PLUS-Mini (60 uA/M) | EBI, LLC | LOE | 2014-09-19 |
| 00812301020133 | SpF®-PLUS-Mini (60 uA/W) | EBI, LLC | LOE | 2014-09-19 |