Putty Syringe with Cannula 2.5cc NB6502

GUDID 00813909013985

Synthetic bone void filler for orthopedic applications

NOVABONE PRODUCTS, LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00813909013985
• NIH Device Record Key: d5639241-32cc-4bc0-8be9-1ab285cf2074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Putty Syringe with Cannula 2.5cc
• Version Model Number: NB6502
• Catalog Number: NB6502
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813909013985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101860

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: 2026-02-05
• Device Publish Date: 2026-01-28

Devices Manufactured by NOVABONE PRODUCTS, LLC

• 00813909013985 - Putty Syringe with Cannula 2.5cc: 2026-02-05Synthetic bone void filler for orthopedic applications
• 00813909013985 - Putty Syringe with Cannula 2.5cc: 2026-02-05 Synthetic bone void filler for orthopedic applications
• 00813909013992 - Putty Syringe with Cannula 5.0cc: 2026-02-05 Synthetic bone void filler for orthopedic applications
• 00813909014005 - Putty Syringe with Cannula 10.0cc: 2026-02-05 Synthetic bone void filler for orthopedic applications
• 00813909013961 - Putty Syringe 2.5cc: 2026-01-19 Synthetic bone void filler for orthopedic applications
• 00813909013978 - Putty Syringe 5.0cc: 2026-01-19 Synthetic bone void filler for orthopedic applications
• 00813909013909 - Putty 2.5cc: 2026-01-05 Synthetic bone void filler for orthopedic applications
• 00813909013916 - Putty 5.0cc: 2026-01-05 Synthetic bone void filler for orthopedic applications
• 00813909013923 - Porous Morsels 1-2mm 5.0cc: 2026-01-05 Synthetic bone void filler for orthopedic applications