ForceBraid™

GUDID B048VAL2024BT1

VALERIS MEDICAL LLC

Polyolefin suture, multifilament

• Primary Device ID: B048VAL2024BT1
• NIH Device Record Key: d13b5412-8caa-477b-b6e0-4cd40429f672
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ForceBraid™
• Version Model Number: 01
• Company DUNS: 079444554
• Company Name: VALERIS MEDICAL 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: true
• Expiration Date: true
• 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
HIBCC	B048VAL2024BT0 [Primary]
HIBCC	B048VAL2024BT1 [Package]; Contains: B048VAL2024BT0; Package: Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150438

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-03-14

On-Brand Devices [ForceBraid™]

• 10818614021222: VAL2020WGT
• 10818614020768: VAL2024WT
• 10818614020751: VAL2024BT
• 10818614020744: VAL2020WT
• 10818614020737: VAL2020BBT
• 10818614020720: VAL2016WT
• 10818614020713: VAL2016BT
• 10818614020690: VAL2030WT
• 10818614020683: VAL2030BT
• 10818614020096: VAL0236GL
• B048VAL2030WT0: ForceBraid™ Suture Tape White
• B048VAL2030BT0: ForceBraid™ Suture Tape Blue
• B048VAL2024WT1: 01
• B048VAL2024BT1: 01
• VAL2020WT1: 01
• B048VAL2020BT1: ForceBraid™ Suture Tape, Blue, 20"
• B048VAL2016WT1: ForceBraid™ Suture Tape, White, 16"
• B048VAL2016BT0: ForceBraid™ Suture Tape, Blue, 16"
• B048VAL0236GL0: ForceBraid™ Suture with Loop