Osteomesh

GUDID 08885013200546

Dimensions: 13 x 8 x 4 x 6 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.

OSTEOPORE INTERNATIONAL PTE. LTD.

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 08885013200546
• NIH Device Record Key: 76983c4e-f64d-4b6b-afa5-ec6bb6a38e3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteomesh
• Version Model Number: PC51(13,8,4,6)
• Company DUNS: 894834738
• Company Name: OSTEOPORE INTERNATIONAL PTE. 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com
• Phone: 9999999999
• Email: customerservice@osteopore.com

Device Dimensions

• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter
• Length: 13 Millimeter
• Width: 8 Millimeter
• Depth: 4 Millimeter
• Height: 6 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08885013200546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051093

FDA Product Code

• GXP: Methyl Methacrylate For Cranioplasty

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: 2020-08-18
• Device Publish Date: 2020-08-10

On-Brand Devices [Osteomesh]

• 08885013200126: Dimensions: 50 x 50 x 1.25 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Fill
• 08885013200119: Dimensions: 50 x 50 x 1 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is
• 08885013200577: Dimensions: 39 x 10 x 1 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler i
• 08885013200546: Dimensions: 13 x 8 x 4 x 6 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Fille
• 08885013200508: Dimensions: 39 x 10 x 1.25 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Fille
• 08885013200140: Dimensions: 50 x 50 x 2 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler i
• 08885013200041: Dimensions: 25 x 25 x 1 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler i
• 08885013200133: Dimensions: 50 x 50 x 1.5 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler