Bioviva-3D Dental

GUDID 00817169021063

Bioviva PGCL 4-0 19mm 3/8 reverse cutting 75CM violet One Device

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Polyester suture, bioabsorbable, monofilament

• Primary Device ID: 00817169021063
• NIH Device Record Key: 3610a500-1cb8-441c-b321-ddd577339d7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioviva-3D Dental
• Version Model Number: SPGC40
• 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	00817169020936 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	00817169021063 [Primary]
GS1	10817169021060 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142810

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• 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