AnchorKnot Tissue Approximation Kit

GUDID 00685447001768

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

Baylis Médicale Cie 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 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: 00685447001768
• NIH Device Record Key: e666444e-a2c7-4320-a0db-bb157f3561b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnchorKnot Tissue Approximation Kit
• Version Model Number: PSZ-400-312
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie 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

Customer Support Contacts

• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447001768 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-30

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• 00685447005971 - SupraCross Steerable Sheath: 2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
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