KARTUSH HA DISC 7MM HA

GUDID 00821925021433

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

• Primary Device ID: 00821925021433
• NIH Device Record Key: f9e9e956-b8bb-46a5-a848-ba9b542e389c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KARTUSH HA DISC 7MM HA
• Version Model Number: 70921784
• 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
• 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	00821925021433 [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.

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• 00821925043930 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
• 00821925043978 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
• 00821925043992 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron
• 00821925044074 - SOLTIVE: 2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron
• 00821925002074 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
• 00821925002098 - USA Elite System: 2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
• 00821925002111 - USA Elite System: 2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold