Otomag™ Alpha 2 Sound Processor

GUDID 00643169671546

PROCSR S0415-03 ALPH 2 LOPRO SI MRI COND

MEDTRONIC XOMED, INC.

Head-worn bone-conduction hearing aid

• Primary Device ID: 00643169671546
• NIH Device Record Key: 4cc9d8ca-6b7e-40a5-affd-dabaa5079735
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otomag™ Alpha 2 Sound Processor
• Version Model Number: S0415-03
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• 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: 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169671546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100193

FDA Product Code

• LXB: Hearing aid, bone conduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-15

On-Brand Devices [Otomag™ Alpha 2 Sound Processor]

• 00643169799844: PROCSR S0415-02 ALPH2LP AN MRI COND ROHS
• 00643169799837: PROCSR S0415-01 ALPH2LP CH MRI COND ROHS
• 00643169799820: PROCSR S0415-00 ALPH2LP BR MRI COND ROHS
• 00643169671546: PROCSR S0415-03 ALPH 2 LOPRO SI MRI COND
• 00643169671539: PROCSR S0415-03 ALPH 2 LOPRO SI MRI UNSF
• 00643169671522: PROCSR S0415-02 ALPH 2 LOPRO AN MRI COND
• 00643169671515: PROCSR S0415-02 ALPH 2 LOPRO AN MRI UNSF
• 00643169671508: PROCSR S0415-01 ALPH 2 LOPRO CH MRI COND
• 00643169671492: PROCSR S0415-01 ALPH 2 LOPRO CH MRI UNSF
• 00643169671485: PROCSR S0415-00 ALPH 2 LOPRO BR MRI UNSF
• 00643169671478: PROCSR S0415-00 ALPH 2 LOPRO BR MRI COND
• 00643169645325: MAGNETIC IMPLANT S0521-00 STER MRI COND
• 00643169645295: PROCESSOR S0415-03 ALPHA2MPO SI MRI UNSF
• 00643169645288: PROCESSOR S0415-02 ALPHA2MPO AN MRI UNSF
• 00643169645271: PROCESSOR S0415-01 ALPHA2MPO CH MRI UNSF
• 00643169645264: PROCESSOR S0415-00 ALPHA2MPO BR MRI UNSF
• 00643169644625: IMPLANT S0521-00 MAGNETIC STER MRI COND
• 00643169644595: PROCESSOR S0415-03 ALPHA2MPO SI MRI COND
• 00643169644588: PROCESSOR S0415-02 ALPHA2MPO AN MRI COND
• 00643169644571: PROCESSOR S0415-01 ALPHA2MPO CH MRI COND
• 00643169644564: PROCESSOR S0415-00 ALPHA2MPO BR MRI COND