OSTEO-Flex

GUDID 00850011613023

Resorbable Collagen Membrane

COLLAGEN MATRIX, INC.

Collagen dental regeneration membrane

• Primary Device ID: 00850011613023
• NIH Device Record Key: f3768fca-f66f-4ff1-aa14-a189f9fe9783
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTEO-Flex
• Version Model Number: OSTEOF30x40
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011613023 [Primary]

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: 2019-10-28
• Device Publish Date: 2019-10-18

On-Brand Devices [OSTEO-Flex]

• 00850011613023: Resorbable Collagen Membrane
• 00850011613016: Resorbable Collagen Membrane
• 00850011613009: Resorbable Collagen Membrane