XP-Seal

GUDID 08800048502175

Resorbable Collagen Membrane

HYUNDAI BIOLAND Co., Ltd.

Collagen dental regeneration membrane

• Primary Device ID: 08800048502175
• NIH Device Record Key: b670fc1b-2f16-483a-b5ed-4dfe000bc697
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XP-Seal
• Version Model Number: XP-2
• 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: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter
• Length: 30 Millimeter
• Width: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800048502175 [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: 2021-09-27
• Device Publish Date: 2021-09-17

On-Brand Devices [XP-Seal]

• 08800048502182: Resorbable Collagen Membrane
• 08800048502175: Resorbable Collagen Membrane
• 08800048502168: Resorbable Collagen Membrane