BIOTRONIK 445633
GUDID 04035479166120
BIOTRONIK SE & Co. KG
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer| Primary Device ID | 04035479166120 |
| NIH Device Record Key | 2e0158fa-f60d-46fc-afee-5bafe290fe56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOTRONIK |
| Version Model Number | BIOwand |
| Catalog Number | 445633 |
| Company DUNS | 315620229 |
| Company Name | BIOTRONIK SE & Co. KG |
| 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 | 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
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479166120 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P210037
FDA Product Code
| LGW | Stimulator, spinal-cord, totally implanted for pain relief |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-14 |
| Device Publish Date | 2023-04-06 |
On-Brand Devices [BIOTRONIK]
| 04035479140748 | BS IS4 |
| 04035479140755 | BS IS4 |
| 04035479177416 | MyHomeStream 2100.U |
| 04035479177409 | HomeStreamCP 2100.U |
| 04035479170356 | Resilience 55TR |
| 04035479170349 | Resilience 75TR |
| 04035479170332 | Resilience 55 |
| 04035479170325 | Resilience 75 |
| 04035479184315 | SCS PP |
| 04035479170301 | Tunneler |
| 04035479170288 | SCS NDL L |
| 04035479184322 | SCS Anchor |
| 04035479170257 | SCS Resilience Acc |
| 04035479170165 | Prospera IOC |
| 04035479170158 | Prospera Trial Acc |
| 04035479170141 | Neuro M50 |
| 04035479170127 | Prospera EPG |
| 04035479170110 | Prospera IPG |
| 04035479170103 | Prospera CHG |
| 04035479166120 | BIOwand |
| 04035479177850 | BIOMONITOR IV |
| 04035479174040 | Amvia Sky HF-T QP |
| 04035479174033 | Amvia Sky HF-T |
| 04035479174026 | Amvia Sky DR-T |
| 04035479174019 | Amvia Sky SR-T |
| 04035479174002 | Amvia Edge HF-T QP |
| 04035479173999 | Amvia Edge DR-T |
| 04035479173982 | Amvia Edge SR-T |
| 04035479173944 | Solvia Rise DR-T |
| 04035479173937 | Solvia Rise SR-T |
| 04035479182977 | PSW 2302.U |
| 04035479182960 | NEO 2302.U |
| 04035479184575 | TrueLock |
Trademark Results [BIOTRONIK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOTRONIK 79322962 not registered Live/Pending |
BIOTRONIK SE & Co. KG 2021-06-07 |
 BIOTRONIK 73574440 1403015 Live/Registered |
BIOTRONIK SALES, INC. 1985-12-20 |
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