Augma Shield

GUDID 08800026800347

AUGMA BIOMATERIALS LTD

General oral wound dressing, non-animal-derived, non-sterile General oral wound dressing, non-animal-derived, non-sterile General oral wound dressing, non-animal-derived, non-sterile General oral wound dressing, non-animal-derived, non-sterile General oral wound dressing, non-animal-derived, non-sterile General oral wound dressing, non-animal-derived, non-sterile General oral wound dressing, non-animal-derived, non-sterile

• Primary Device ID: 08800026800347
• NIH Device Record Key: 5a69f5f4-103c-4bf2-9757-97d6efe7b539
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Augma Shield
• Version Model Number: OB23
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800026800347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211851

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-23
• Device Publish Date: 2022-06-15

Devices Manufactured by AUGMA BIOMATERIALS LTD

• 07290014838062 - 3D Bond: 2024-03-11
• 08800026800347 - Augma Shield: 2022-06-23
• 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: 2018-03-29 Bond Apatite® is a synthetic, ‎osteoconductive, composite graft cement ‎composed of biphasic calcium sulfate and ‎hydroxy