AnchorAccess #1 Dilator

GUDID 00685447002000

Baylis Médicale Cie Inc

Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable Fascial tissue dilator, reusable

• Primary Device ID: 00685447002000
• NIH Device Record Key: 01df1502-0197-4dfb-af69-0d3a694a456c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnchorAccess #1 Dilator
• Version Model Number: PSZ-300-204
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00685447002000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161878

FDA Product Code

• HRX: Arthroscope

Sterilization

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

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

[00685447002000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-16

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• 00685447019060 - VersaCross Connect Access Solution for FARADRIVE: 2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
• 00685447019077 - VersaCross Connect Access Solution for FARADRIVE: 2024-01-19 1 x VersaCross Connect Transseptal Dilator; 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
• 00685447005964 - SupraCross Steerable Sheath: 2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005971 - SupraCross Steerable Sheath: 2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447005988 - SupraCross Steerable Sheath: 2023-11-16 SupraCross Steerable Sheath; Transseptal Dilator; J-Tip Guidewire
• 00685447006213 - SureFlex Steerable Guiding Sheath: 2023-11-16 SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire