ET Convertible GoldCast Cylinder

GUDID 00810125996405

HIOSSEN, INC.

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• Primary Device ID: 00810125996405
• NIH Device Record Key: b9ed0a8a-67aa-4761-9cb0-fa8aa3795b77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Convertible GoldCast Cylinder
• Version Model Number: ETGC400NCWH
• Company DUNS: 796083090
• Company Name: HIOSSEN, 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810125996405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222636

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-01
• Device Publish Date: 2024-06-21

On-Brand Devices [ET Convertible GoldCast Cylinder ]

• 00810125996429: ETGC600CWH
• 00810125996412: ETGC500CWH
• 00810125996405: ETGC400NCWH
• 00810125996399: ETGC400CWH