Remplir™

GUDID 19358206000071

ORTHOCELL LIMITED

Nerve guide, animal-derived

• Primary Device ID: 19358206000071
• NIH Device Record Key: ba4658d0-4904-4397-a9b5-a5e7995a9404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remplir™
• Version Model Number: ON-405
• 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: 40 Millimeter
• Length: 50 Millimeter
• Width: 40 Millimeter
• Length: 50 Millimeter
• Width: 40 Millimeter
• Length: 50 Millimeter
• Width: 40 Millimeter
• Length: 50 Millimeter
• Width: 40 Millimeter
• Length: 50 Millimeter
• Width: 40 Millimeter
• Length: 50 Millimeter
• Width: 40 Millimeter
• Length: 50 Millimeter
• Width: 40 Millimeter
• Length: 50 Millimeter
• Width: 40 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	09358206000074 [Primary]
GS1	19358206000071 [Package]; Contains: 09358206000074; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243889

FDA Product Code

• JXI: Cuff, Nerve

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: 2025-04-15
• Device Publish Date: 2025-04-07

On-Brand Devices [Remplir™]

• 19358206000071: ON-405
• 09358206000067: ON-304
• 09358206000050: ON-203
• 19358206000040: ON-152