Axiom® Lig-A-Boots®

GUDID M6653003

Instrument Jaw Covers, White

AXIOM MEDICAL, INCORPORATED

Vascular booties

• Primary Device ID: M6653003
• NIH Device Record Key: 9766798c-4e3d-42ee-814c-b138ad29b634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiom® Lig-A-Boots®
• Version Model Number: 300
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M6653000 [Primary]
HIBCC	M6653001 [Package]; Contains: M6653000; Package: Box [5 Units]; In Commercial Distribution
HIBCC	M6653003 [Package]; Contains: M6653001; Package: Case [10 Units]; In Commercial Distribution
HIBCC	M6653005 [Package]; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820161

FDA Product Code

• KDC: Instrument, Surgical, Disposable

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: 2021-06-29
• Device Publish Date: 2018-09-23

Devices Manufactured by AXIOM MEDICAL, INCORPORATED

• M6651000083 - Axiom®: 2024-01-03 Thoracic Catheter, Straight, Silicone
• M665100008AT3 - Axiom® Atraum™ With ClotStop®: 2024-01-03 Thoracic Catheter, Straight, Silicone, With ClotStop®
• M665100008ATS3 - Axiom® Atraum™ With ClotStop®: 2024-01-03 Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®
• M665100008ATSC3 - Axiom® Atraum™ With ClotStop®: 2024-01-03 Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®
• M665100008S3 - Axiom®: 2024-01-03 Thoracic Catheter, Straight, Silicone, With Scale
• M665100008SC3 - Axiom®: 2024-01-03 Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched
• M6651000103 - Axiom®: 2024-01-03 Thoracic Catheter, Straight, Silicone
• M665100010AT3 - Axiom® Atraum™ With ClotStop®: 2024-01-03 Thoracic Catheter, Straight, Silicone, With ClotStop®