THE Cover

GUDID 08800039003742

Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers from penetrating the damaged area. THE Cover induces cell proliferation from the periodontal ligament and alveolar bone.

PURGO BIOLOGICS Inc.

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: 08800039003742
• NIH Device Record Key: 138fde4a-85e7-4f98-a2df-7b8ab3b3cea0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THE Cover
• Version Model Number: BP3-1520
• Company DUNS: 687429456
• Company Name: PURGO BIOLOGICS 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 Identifiers

Device Issuing Agency	Device ID
GS1	08800039003742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230091

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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [THE Cover]

• 08800039003810: Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover pr
• 08800039003803: Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover pr
• 08800039003797: Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover pr
• 08800039003780: Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover pr
• 08800039003773: Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover pr
• 08800039003766: Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover pr
• 08800039003759: Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover pr
• 08800039003742: Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover pr