Meniett

GUDID 00721902541094

GENERATOR 1010020401LO LOANER MENIETT US

MEDTRONIC XOMED, INC.

Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use

• Primary Device ID: 00721902541094
• NIH Device Record Key: ebb74153-45d1-47f4-9600-aa679c27eed4
• Commercial Distribution Discontinuation: 2018-10-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Meniett
• Version Model Number: 1010020401LO
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902541094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991562

FDA Product Code

• ETY: TESTER, AUDITORY IMPEDANCE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-05
• Device Publish Date: 2016-05-02

On-Brand Devices [Meniett]

• 00721902541094: GENERATOR 1010020401LO LOANER MENIETT US
• 00721902265846: GENERATOR 1010020401 MENIETT 20 US