KARTUSH HA DISK 20MM HA

GUDID 00821925021471

Means of reconstruction of natural or surgically created defects of the mastoid lining the canal wall or the attic of the tympanic cavity

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

• Primary Device ID: 00821925021471
• NIH Device Record Key: 7c7e6275-a18d-4e3f-9d00-692e18d3f4a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KARTUSH HA DISK 20MM HA
• Version Model Number: 70921787
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925021471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863237

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

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)