OFFCENTERED TORP 8MM LENGTH 084MM DIAMETER DENSE HYDROXYLAPATITE

GUDID 00821925015302

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

• Primary Device ID: 00821925015302
• NIH Device Record Key: b4d879b6-0254-4c51-99fc-0e3bfc55909c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OFFCENTERED TORP 8MM LENGTH 084MM DIAMETER DENSE HYDROXYLAPATITE
• Version Model Number: 140891
• 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: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx
• Phone: 1(800)262-3540
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925015302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802431

FDA Product Code

• ETB: Prosthesis, Partial Ossicular Replacement

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.

• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
• 00810008180990 - nCare: 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
• 00810008180501 - nCare: 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180952 - nCare: 2023-09-25 nCare, SNGL,DRCT SDI,DICOM
• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)