Bond Apatite

GUDID 17290014838021

Bond Apatite® is a synthetic, ‎osteoconductive, composite graft cement ‎composed of biphasic calcium sulfate and ‎hydroxyapatite granules. Bond Apatit

AUGMA BIOMATERIALS LTD

Synthetic bone graft

• Primary Device ID: 17290014838021
• NIH Device Record Key: 3cc732ee-9a49-4285-bc95-54bff365bcd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bond Apatite
• Version Model Number: HA-BB-Pack1
• Company DUNS: 533432352
• Company Name: AUGMA BIOMATERIALS 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014838024 [Primary]
GS1	17290014838021 [Package]; Contains: 07290014838024; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-10

Devices Manufactured by AUGMA BIOMATERIALS LTD

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• 08800026800347 - Augma Shield: 2022-06-23
• 07290014838055 - 3D Bond+: 2022-06-21
• 17290014838007 - 3D Bond: 2018-07-06 ‎3D Bond is a synthetic, osteoconductive, ‎bioresorbable graft binder cement composed ‎of biphasic Calcium Sulfate in a g
• 17290014838014 - 3D Bond: 2018-07-06 ‎3D Bond is a synthetic, osteoconductive, ‎bioresorbable graft binder cement composed ‎of biphasic Calcium Sulfate in a g
• 17290014838021 - Bond Apatite: 2018-03-29Bond Apatite® is a synthetic, ‎osteoconductive, composite graft cement ‎composed of biphasic calcium sulfate and ‎hydroxyapatite granules. Bond Apatit
• 17290014838021 - Bond Apatite: 2018-03-29 Bond Apatite® is a synthetic, ‎osteoconductive, composite graft cement ‎composed of biphasic calcium sulfate and ‎hydroxy