Otomag™ Monaural Softband

GUDID 00643169645011

SOFTBAND S0264-31 CAFE MONAURAL

MEDTRONIC XOMED, INC.

Head-worn bone-conduction hearing aid Head-worn bone-conduction hearing aid Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn Bone-conduction hearing aid, head-worn

• Primary Device ID: 00643169645011
• NIH Device Record Key: 253a133b-55b1-4e98-b648-2e7efad26882
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otomag™ Monaural Softband
• Version Model Number: S0264-31
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169645011 [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: 2016-04-17

On-Brand Devices [Otomag™ Monaural Softband]

• 00643169645035: SOFTBAND S0264-41 PALE PINK MONAURAL
• 00643169645011: SOFTBAND S0264-31 CAFE MONAURAL
• 00643169644991: SOFTBAND S0264-21 WHITE MONAURAL
• 00643169644977: SOFTBAND S0264-11 BLACK MONAURAL