PowerKnot High Strength Sutures

GUDID 07630345748850

PowerKnot RDI, #2, black/blue/white w/ needle

Medacta International SA

Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: 07630345748850
• NIH Device Record Key: 39eb2b25-1baa-4119-8d41-c2fa7707cef6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerKnot High Strength Sutures
• Version Model Number: 05.03.0005
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630345748850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252225

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2025-09-26
• Device Publish Date: 2025-09-18

On-Brand Devices [PowerKnot High Strength Sutures]

• 07630345748898: PowerKnot, #2, white/blue w/ needle
• 07630345748881: PowerKnot, #2, white/blue
• 07630345748874: PowerKnot, #2, white/black w/ needle
• 07630345748867: PowerKnot, #2, white/black
• 07630345748850: PowerKnot RDI, #2, black/blue/white w/ needle
• 07630345748843: PowerKnot RDI, #2, black/blue/white