Single Use Eartip

GUDID 00846430004160

Eartip 12mm 100pk

ETYMOTIC RESEARCH, INC.

Audiometric ear tip

• Primary Device ID: 00846430004160
• NIH Device Record Key: ae8110f7-cfe7-4f14-98b6-653e6d1a1e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Eartip
• Version Model Number: ER10D-T12
• Company DUNS: 115380859
• Company Name: ETYMOTIC RESEARCH, 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: 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: false
• OTC Over-The-Counter: true

Device Dimensions

• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846430004160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930553

FDA Product Code

• EWO: Audiometer

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: 2016-09-20

On-Brand Devices [Single Use Eartip]

• 00846430004191: Eartip 16mm 100pk
• 00846430004184: Eartip 14mm 100pk
• 00846430004177: Eartip 13mm 100pk
• 00846430004160: Eartip 12mm 100pk
• 00846430004153: Eartip 11mm 100pk
• 00846430004139: 9mm Single Use Ear tip 100pk
• 00846430004122: 8mm single use eartip 100pk
• 00846430004115: 7mm Single Use Ear tip 100pk
• 00846430004108: 6mm Single Use Ear tip 100pk
• 00846430004092: 5mm Single Use Eartip 100pk
• 00846430004085: 4mm Ear tip 100pk
• 00846430004078: 3mm Single Use Eartip 100pk