PROSTHESIS SHEA TEF CUP S

GUDID 00821925023840

Gyrus Acmi, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00821925023840
• NIH Device Record Key: 6f5f972c-b221-4870-bec4-36b0d04ff60d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROSTHESIS SHEA TEF CUP S
• Version Model Number: 902087
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925023840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K760433

FDA Product Code

• ETA: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-04

On-Brand Devices [PROSTHESIS SHEA TEF CUP S]

• 00821925023840: 902087
• 00821925023833: 902085