RENOVATIO

GUDID 00850046400025

TWISTR PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE

Bonago Medical Solutions LLC

Polydioxanone/polyethylene suture

• Primary Device ID: 00850046400025
• NIH Device Record Key: 825dbe57-5579-451f-8932-a81cfdc3a48e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENOVATIO
• Version Model Number: REN-TWIST-27-50
• Company DUNS: 118712410
• Company Name: Bonago Medical Solutions LLC
• Device Count: 10
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850046400025 [Unit of Use]
GS1	10850046400022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160761

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

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: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [RENOVATIO]

• 10850046400008: TWISTR PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400186: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400155: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400247: TWISTR PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400230: TWISTR PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400223: TWISTR PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400216: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400209: DUAL NEEDLE HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400193: DUAL NEEDLE HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZEDPACKAGE
• 00850046400179: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400162: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400148: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400131: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400124: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400117: SOFT PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400100: SOFT PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400094: RHINO HYBRID PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400087: RHINO HYBRID PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400070: MESH HYBRID PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400063: MESH HYBRID PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400056: TWISTR PUSH PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400049: TWISTR PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400032: TWISTR PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400025: TWISTR PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400018: TWISTR PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400278: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400261: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE
• 00850046400254: HARPOON PDO THREAD BIOABSORBABLE WITH NEEDLE-STERILIZED PACKAGE