3D Dental- Bioviva

GUDID 00817169021964

Bioviva Soluble Dental Hemostatic Gauze

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

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

• Primary Device ID: 00817169021964
• NIH Device Record Key: 4c0501fd-1c05-434f-8711-02e31bbd469c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Dental- Bioviva
• Version Model Number: BHG
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, 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 Identifiers

Device Issuing Agency	Device ID
GS1	00817169021964 [Primary]

FDA Product Code

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

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: 2018-10-01
• Device Publish Date: 2018-08-30

On-Brand Devices [3D Dental- Bioviva]

• 00817169021964: Bioviva Soluble Dental Hemostatic Gauze
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• 10817169021619: BIOVIVA SUTURE PLAIN GUT C-31 3/0 18"
• 10817169021596: BIOVIVA SUTURE PLAIN GUT C-6 3/0 18"
• 10817169021572: BIOVIVA SUTURE PLAIN GUT C-6 4/0 27"
• 10817169021558: BIOVIVA SUTURE CHROMIC GUT C-6 3/0 27"
• 00817169021537: BIOVIVA SUTURE CHROMIC GUT C-6 4/0 27"
• 00817169021513: BIOVIVA SUTURE CHROMIC GUT C-6 3/0 18"
• 00817169021506: BIOVIVA SUTURE CHROMIC GUT C-6 4/0 18" 12/BX
• 00817169021490: BIOVIVA SUTURE CHROMIC GUT C-6 4/0 18"