GYRUS ACMI, INC

GUDID 00821925016118

SHAH DISC LARGE 9.5 MM DIAMETER SILICONE

Gyrus Acmi, Inc.

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00821925016118
• NIH Device Record Key: dd721054-6bfb-4250-9633-639fa54ea389
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GYRUS ACMI, INC
• Version Model Number: 140176
• 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	00821925016118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992222

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [GYRUS ACMI, INC]

• 00821925016118: SHAH DISC LARGE 9.5 MM DIAMETER SILICONE
• 00821925016101: SHAH DISC SMALL 8.5 MM DIAMETER SILICONE
• 00821925007819: REX 6.9Fr URETEROSCOPE, 43cm
• 00821925003446: AMPLATZ Guidewire 0.038" (0.97mm) x 150cm Sper Stiff Body, 9cm Straight Tip
• 00821925002579: SEMI-RIGID GYNECOLOGIC SCISSORS, 32 CM