SHEA PORP 55 MM LENGTH30 MM HEAD DIAMETER DENSE HYDROXYLAPATITE PLASTIPORE

GUDID 00821925015371

Replace the portion of the ossicular chain that has lost its function due to disease congenital defect or other pathological process

Gyrus Acmi, Inc.

Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00821925015371
• NIH Device Record Key: e1d14c62-25d1-4dc7-a5b4-4c3a8300c204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHEA PORP 55 MM LENGTH30 MM HEAD DIAMETER DENSE HYDROXYLAPATITE PLASTIPORE
• Version Model Number: 140898
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925015371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864444

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: 2015-10-24

Devices Manufactured by Gyrus Acmi, Inc.

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• 00821925041400 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 30DEG, TOP LIGHT INSTACLEAR
• 00821925041417 - InstaClear: 2024-04-30 SHEATH LENS CLEANER ULTRA 30DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041424 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, TOP LIGHT INSTACLEAR
• 00821925041431 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041448 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR
• 00821925041455 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR
• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG