ForceBraid

GUDID B048VAL2020WGT0

Suture Tape

VALERIS MEDICAL LLC

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• Primary Device ID: B048VAL2020WGT0
• NIH Device Record Key: 9a247f5a-7ea6-4a76-832c-5c5506133d92
• 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	B048VAL2020WGT0 [Primary]
HIBCC	B048VAL2020WGT1 [Package]; 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: 2017-01-25

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