Axiom® CWV Facial Atraum™ With ClotStop®

GUDID M665412AT3

Closed Wound Facial Drains (Two), Flat, Silicone, With Bifurcated Connector, With ClotStop®

AXIOM MEDICAL, INCORPORATED

Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable

• Primary Device ID: M665412AT3
• NIH Device Record Key: 08294b9d-aaeb-4239-a0da-05c94bab8b07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiom® CWV Facial Atraum™ With ClotStop®
• Version Model Number: 412AT
• Company DUNS: 094439676
• Company Name: AXIOM MEDICAL, INCORPORATED
• 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: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M665412AT0 [Primary]
HIBCC	M665412AT1 [Package]; Contains: M665412AT0; Package: Box [10 Units]; In Commercial Distribution
HIBCC	M665412AT3 [Package]; Contains: M665412AT1; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883887

FDA Product Code

• GBS: Catheter, Ventricular, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-08
• Device Publish Date: 2018-09-23

On-Brand Devices [Axiom® CWV Facial Atraum™ With ClotStop®]

• M665410ATSX1: Closed Wound Drain, Flat, Silicone, With ClotStop®, Special Length
• M665800410AT3: Closed Wound Drain, Flat, Silicone, With Trocar, With ClotStop®
• M665412ATSX1: Closed Wound Facial Drains (Two), Flat, Silicone, With Bifurcated Connector, With ClotStop®, Sp
• M665412AT3: Closed Wound Facial Drains (Two), Flat, Silicone, With Bifurcated Connector, With ClotStop®
• M665410AT3: Closed Wound Drain, Flat, Silicone, With ClotStop®