BIOTRONIK 457857

GUDID 04035479170288

BIOTRONIK SE & Co. KG

Epidural needle, non-threaded

• Primary Device ID: 04035479170288
• NIH Device Record Key: 51f4dfb7-96b5-481e-aff5-3d36c81e6f67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOTRONIK
• Version Model Number: SCS NDL L
• Catalog Number: 457857
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479170288 [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: true

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