Inion GTR™ TCK-2011

GUDID 06438408005565

Tacks, drill bit and tack appl.

Inion Oy

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• Primary Device ID: 06438408005565
• NIH Device Record Key: 8fcd8134-92c6-4ec3-aaf7-f3e38ea62cbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion GTR™
• Version Model Number: 1
• Catalog Number: TCK-2011
• Company DUNS: 367994657
• Company Name: Inion Oy
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	06438408005565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033074

FDA Product Code

• NPK: Barrier, synthetic, intraoral

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: 2023-12-27
• Device Publish Date: 2023-12-19

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• M224TCK20029: Tacks and drill bit
• M224MBR20009: Membrane 30x40 mm
• 06438408010750: Membrane 30x40 mm
• 06438408007279: Tacks and drill bit
• 06438408005572: Tacks (4 x)
• 06438408005565: Tacks, drill bit and tack appl.