Bioviva by 3D Dental SCG122

GUDID 00810126505521

BIOVIVA SUTURE CHROMIC GUT TAPER POINT 3-0 SH 1/2 27" 26MM

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

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• Primary Device ID: 00810126505521
• NIH Device Record Key: eb81840b-ecfc-4c60-b423-9dc91de6d12e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioviva by 3D Dental
• Version Model Number: SCG122
• Catalog Number: SCG122
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	00810126505521 [Primary]
GS1	10810126505528 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• GAL: Suture, Absorbable, Natural

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: 2023-12-12
• Device Publish Date: 2023-12-04

On-Brand Devices [Bioviva by 3D Dental]

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• 00810126505620: BIOVIVA SUTURE CHROMIC GUT TAPER POINT 4-0 RB1 1/2 27" 18MM
• 00810126505521: BIOVIVA SUTURE CHROMIC GUT TAPER POINT 3-0 SH 1/2 27" 26MM
• 10810126503418: BIOVIVA SUTURE CHROMIC GUT REVERSE CUTTING 5/0 P-3 3/8 18" 13MM
• 00810126506580: Bioviva Suture Chromic Gut 3/0 27",Taper Point,1/2, 18mm RB1 Needle Single