Bioviva-3D Dental

GUDID 00817169021100

Basik PDO SUTURE USP 4-0 -3/8 CIRCLE REVERSE CUTTING..19 MM NEEDLE 30" LENGTH One Device

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Polyester suture, bioabsorbable, monofilament Polyester suture, bioabsorbable, monofilament Polyester suture, bioabsorbable, monofilament Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 00817169021100
• NIH Device Record Key: 1166b30d-f5cb-4104-921f-6d1623868651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioviva-3D Dental
• Version Model Number: BPDO397
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817169020974 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	00817169021100 [Primary]
GS1	10817169021107 [Package]; Contains: 00817169020974; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073614

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-12-15

On-Brand Devices [Bioviva-3D Dental]

• 00817169021148: Basik PGC SUTURE USP 4/0..3/8 REV CUTTING NEEDLE 19MM LENGTH Box of 12
• 00817169021131: Basik PGC SUTURE USP 3/0..3/8 REV CUTTING NEEDLE 24MM LENGTH One Device
• 00817169021124: Basik PGC SUTURE USP 2/0..3/8 REV CUTTING NEEDLE 30MM LENGTH One Device
• 00817169021117: Basik PGC SUTURE USP 0..3/8 REV CUTTING NEEDLE 30MM LENGTH One Device
• 00817169021100: Basik PDO SUTURE USP 4-0 -3/8 CIRCLE REVERSE CUTTING..19 MM NEEDLE 30" LENGTH One Device
• 00817169021094: Basik PDO SUTURE USP 3/0 -3/8 CIRCLE REVERSE CUTTING..24MM NEEDLE 30" LENGTH One Device
• 00817169021087: Basik PDO USP 2/0 -3/8 CIRCLE REVERSE CUTTING..24MM NEEDLE 30" LENGTH One Device
• 00817169021070: Basik PDO SUTURE USP 0 -3/8 CIRCLE REVERSE CUTTING..30 MM NEEDLE 30" LENGTH One Device
• 00817169021063: Bioviva PGCL 4-0 19mm 3/8 reverse cutting 75CM violet One Device
• 00817169021056: SILK SUTURE 3-0 REVERSE CUTTING 24MM 3/8 45CM One Device
• 00817169021049: SILK SUTURE 4-0 REVERSE CUTTING 19MM 3/8" 45CM One Device
• 00817169020905: Bioviva SILK SUTURE 3-0 REVERSE CUTTING 22MM 1/2" 45CM One Device
• 00817169021025: Bioviva SILK SUTURE 3-0 REVERSE CUTTING 19MM 3/8" 45CM One Device