GUDID 00763000242749

EARPHONES AE102 INSERT ROHS

MEDTRONIC XOMED, INC.

Auditory stimulator

• Primary Device ID: 00763000242749
• NIH Device Record Key: 3e63d9ce-57e7-4613-9b19-07a18a669118
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AE102
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000242749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061639

FDA Product Code

• GXZ: ELECTRODE, NEEDLE

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: 2019-07-15
• Device Publish Date: 2019-07-05

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00763000033385 - HA/C Polycel® Brackmann Total: 2024-05-20 PROSTHESIS 1112303 BRACKMANN H/AC TOTAL
• 00763000034832 - Sheehy HA/C Polycel® P.O.P.: 2024-05-20 PROSTHESIS 1112362 SHEEHY POP H/A POLYCL
• 00763000034849 - Sheehy HA/C Polycel® T.O.P.: 2024-05-20 PROSTHESIS 1112363 SHEEHY TOP H/A POLYCL
• 00763000036591 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156611 PLAT/TI .5X4.5MM LFT
• 00763000036607 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156612 PLAT/TI .5X4.75MM LFT
• 00763000036614 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156613 PLAT/TI .5X5MM LEFT
• 00763000036621 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156621 PLAT/TI .5X4.5MM RT
• 00763000036638 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156622 PLAT/TI .5X4.75M RT