T-Gen

GUDID 08800048502373

Absorbable collagen membrane

HYUNDAI BIOLAND Co., Ltd.

Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane

• Primary Device ID: 08800048502373
• NIH Device Record Key: 33d825c6-85d0-493e-8cd3-9894f2d65566
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Gen
• Version Model Number: TG-4
• Company DUNS: 688235061
• Company Name: HYUNDAI BIOLAND Co., Ltd.
• 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 Dimensions

• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter
• Length: 30 Millimeter
• Width: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800048502373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200623

FDA Product Code

• NPL: Barrier, Animal Source, 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: 2023-04-26
• Device Publish Date: 2023-04-18

On-Brand Devices [T-Gen]

• 08800048502380: Absorbable collagen membrane
• 08800048502373: Absorbable collagen membrane
• 08800048502366: Absorbable collagen membrane
• 08800048502359: Absorbable collagen membrane
• 08800048502342: Absorbable collagen membrane