AnchorKnot Tissue Approximation Kit

GUDID 07540299000150

AnchorKnot Suture Passer (2-0); AnchorKnot Knot Pusher (2-0); AnchorKnot Suture Cutter (2-0)

Baylis Medical Technologies Inc

Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 07540299000150
• NIH Device Record Key: 3a149887-f624-4490-a632-146027ff0d9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnchorKnot Tissue Approximation Kit
• Version Model Number: PSZ-400-312
• Company DUNS: 240389677
• Company Name: Baylis Medical Technologies Inc
• 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: true
• 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	00685447001768 [Previous]
GS1	07540299000150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161878

FDA Product Code

• HRX: Arthroscope

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: 2022-11-24
• Device Publish Date: 2022-11-16

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