Otomag™ Attract™ Magnetic Spacer

GUDID 00643169644793

BASE PLATE S0542-00 0 DOT NATURAL

MEDTRONIC XOMED, INC.

Head-worn bone-conduction hearing aid base plate

• Primary Device ID: 00643169644793
• NIH Device Record Key: 23fce951-7a1e-473c-ba0c-fd8b530944ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Otomag™ Attract™ Magnetic Spacer
• Version Model Number: S0542-00
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169644793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102199

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™ Attract™ Magnetic Spacer]

• 00643169644885: BASE PLATE S0542-21 -1 DOT NATURAL
• 00643169644878: BASE PLATE SET S0542-15 1 SET NATURAL
• 00643169644861: BASE PLATE S0542-07 7 DOT NATURAL
• 00643169644854: BASE PLATE S0542-06 6 DOT NATURAL
• 00643169644847: BASE PLATE S0542-05 5 DOT NATURAL
• 00643169644830: BASE PLATE S0542-04 4 DOT NATURAL
• 00643169644823: BASE PLATE S0542-03 3 DOT NATURAL
• 00643169644816: BASE PLATE S0542-02 2 DOT NATURAL
• 00643169644809: BASE PLATE S0542-01 1 DOT NATURAL
• 00643169644793: BASE PLATE S0542-00 0 DOT NATURAL
• 00643169644786: BASE PLATE S0266-21 -1 DOT BLACK
• 00643169644779: BASE PLATE SET S0266-15 1 SET BLACK
• 00643169644762: BASE PLATE S0266-11 11 DOT BLACK
• 00643169644755: BASE PLATE S0266-10 10 DOT BLACK
• 00643169644748: BASE PLATE S0266-09 9 DOT BLACK
• 00643169644731: BASE PLATE S0266-08 8 DOT BLACK
• 00643169644717: BASE PLATE S0266-06 6 DOT BLACK
• 00643169644700: BASE PLATE S0266-05 5 DOT BLACK
• 00643169644694: BASE PLATE S0266-04 4 DOT BLACK
• 00643169644687: BASE PLATE S0266-03 3 DOT BLACK
• 00643169644670: BASE PLATE S0266-02 2 DOT BLACK
• 00643169644663: BASE PLATE S0266-01 1 DOT BLACK
• 00643169644656: BASE PLATE S0266-00 0 DOT BLACK