NuROs Bone Graft Substitute(Sterile)

GUDID 04716329941141

NuROs Absorbable Bone Graft Substitute is an implant intended to fill bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NuROs Absorbable Bone Graft Substitute is absorbed around 6 months and replaced with bone during the healing process.

ORIENTAL RESOURCES DEVELOPMENT LIMITED BIOMEDICAL FACTORY

Synthetic bone graft

• Primary Device ID: 04716329941141
• NIH Device Record Key: 20073f90-1949-49c1-858f-074ce5f4a094
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuROs Bone Graft Substitute(Sterile)
• Version Model Number: BGD50
• Company DUNS: 658871135
• Company Name: ORIENTAL RESOURCES DEVELOPMENT LIMITED BIOMEDICAL FACTORY
• 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: true
• Expiration Date: false
• 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

• Total Volume: 2.5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716329941141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140913

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2019-05-28
• Device Publish Date: 2019-05-20

On-Brand Devices [NuROs Bone Graft Substitute(Sterile)]

• 04716329941400: NuROs Absorbable Bone Graft Substitute is an implant intended to fill bony voids or gaps of the
• 04716329941141: NuROs Absorbable Bone Graft Substitute is an implant intended to fill bony voids or gaps of the