| Primary Device ID | 09008737520472 |
| NIH Device Record Key | 48b5ae1d-f52b-434e-8cf0-f52825187db0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAMBA 2 |
| Version Model Number | 52047 |
| Catalog Number | 52047 |
| Company DUNS | 300764032 |
| Company Name | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Phone | 1-888-633-3524 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008737520472 [Primary] |
| PFO | Active Implantable Bone Conduction Hearing System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-16 |
| Device Publish Date | 2020-09-08 |
| 09008737527969 | Remote Control |
| 09008737526122 | SAMBA 2 BB User Kit, left |
| 09008737526115 | SAMBA 2 BB User Kit, right |
| 09008737526030 | SAMBA 2 Remote (iOS) |
| 09008737525279 | SAMBA 2 BB AP Unit, left |
| 09008737525262 | SAMBA 2 BB AP Unit, right |
| 09008737525071 | SAMBA 2 GO |
| 09008737520472 | SAMBA 2 Remote (Android) |