Putty 5.0cc NB0605

GUDID 00813909010830

Synthetic bone void filler for orthopedic applications

NOVABONE PRODUCTS, LLC

Bone matrix implant, synthetic Bone matrix implant, synthetic

• Primary Device ID: 00813909010830
• NIH Device Record Key: 07478b0c-41d6-4221-8e52-dd1172d606a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Putty 5.0cc
• Version Model Number: NB0605
• Catalog Number: NB0605
• Company DUNS: 828813290
• Company Name: NOVABONE PRODUCTS, LLC
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813909010830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082672

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-07

Devices Manufactured by NOVABONE PRODUCTS, LLC

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• 00813909012872 - Bioactive Strip 10.0cc Long: 2024-03-12 Bone void filler for orthopedic applications
• 00813909012803 - Putty Syringe 2.5cc: 2023-12-11 Synthetic bone void filler for orthopedic applications
• 00813909012810 - Putty Syringe 5.0cc: 2023-12-11 Synthetic bone void filler for orthopedic applications
• 00813909012827 - Wound Matrix: 2023-12-11 Collagen wound dressing
• 00813909012834 - Wound Matrix: 2023-12-11 Collagen wound dressing
• 00813909012841 - Wound Matrix: 2023-12-11 Collagen wound dressing
• 00813909012858 - Wound Matrix: 2023-12-11 Collagen wound dressing