Bonebridge 52180
GUDID 09008738521805
BCI Bone Conduction Implant Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Implantable vibrator bone-conduction hearing implant system| Primary Device ID | 09008738521805 |
| NIH Device Record Key | e1882ef1-66f6-4c05-bc53-5ea80c0ed006 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bonebridge |
| Version Model Number | 52180 |
| Catalog Number | 52180 |
| 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 | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com | |
| Phone | +1(888)633-3527 |
| implants.us@medel.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool and dry place. |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008738521805 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN170009
FDA Product Code
| PFO | Active Implantable Bone Conduction Hearing System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-25 |
| Device Publish Date | 2019-04-17 |
On-Brand Devices [Bonebridge]
| 09008738521805 | BCI Bone Conduction Implant Kit |
| 09008737524852 | BCI 602 Sizer Kit |
| 09008737524845 | BCI 602 Lifts (1 mm) |
| 09008737524838 | BCI 602 Kit which contains the BCI 602 Implant Kit and the BCI 602 Sizer Kit |
| 09008737522605 | Surgical Screwdriver SD 2 |
| 09008738517846 | SAMBA BB R, AP Unit |
| 09008738517839 | SAMBA BB L, AP Unit |
| 09008738515606 | Samba BB audio processor (Right) |
| 09008738515590 | Samba BB audio processor (Left) |
Trademark Results [Bonebridge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BONEBRIDGE 79084534 4181231 Live/Registered |
Med-El Elektromedizinische Geräte Gesellschaft m.b.H. 2010-05-03 |
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