perFORM™

GUDID 09358206000098

ORTHOCELL LIMITED

Collagen dental regeneration membrane

• Primary Device ID: 09358206000098
• NIH Device Record Key: e4795ef4-6b61-4947-9548-af46f2a50f4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: perFORM™
• Version Model Number: perf2030
• Company DUNS: 754598449
• Company Name: ORTHOCELL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09358206000098 [Primary]
GS1	19358206000095 [Package]; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201241

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 [perFORM™]

• 09358206000104: perf3040
• 09358206000098: perf2030
• 09358206000081: perf1520