Halo One Thin-Walled Guiding Sheath HLO61018H

GUDID 10801741219136

Halo One, 6F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated.

CLEARSTREAM TECHNOLOGIES LIMITED

Vascular guide-catheter, single-use

• Primary Device ID: 10801741219136
• NIH Device Record Key: 05bce840-cb24-4b93-b50a-fb3ada9f7d7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halo One Thin-Walled Guiding Sheath
• Version Model Number: HLO61018H
• Catalog Number: HLO61018H
• Company DUNS: 989214291
• Company Name: CLEARSTREAM TECHNOLOGIES LIMITED
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +1(800)321-4254
• Email: medical.services@bd.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741219139 [Primary]
GS1	10801741219136 [Package]; Contains: 00801741219139; Package: CA [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212708

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2021-11-23
• Device Publish Date: 2021-11-15

On-Brand Devices [Halo One Thin-Walled Guiding Sheath]

• 00801741223891: Halo One 6F guiding sheath diameter, 90cm shaft length, 0.035 dilator
• 00801741223884: Halo One, 6F guiding sheath diameter, 70cm shaft length, 0.035 dilator.
• 00801741223877: Halo One, 6F guiding sheath diameter, 45cm shaft length, 0.035 dilator
• 10801741219136: Halo One, 6F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated.
• 00801741218316: Halo One, 6F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated.
• 00801741218309: Halo One, 5F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated.
• 00801741218293: Halo One, 4F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated.
• 00801741223914: 6F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated, including acce
• 10801741223904: 6F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including acce
• 00801741223860: 6F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including acce
• 10801741223850: 6F guiding sheath diameter, 10cm shaft length, 0.035 dilator, hydrophilic coated, including acce
• 00801741223846: 5F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including acce
• 00801741223839: 5F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated, including acce
• 10801741223829: 5F guiding sheath diameter, 10cm shaft length, 0.035 dilator, hydrophilic coated, including acce
• 10801741223812: 5F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including acce
• 00801741223808: 4F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including acce
• 00801741223792: 4F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated, including acce
• 10801741223782: 4F guiding sheath diameter, 10cm shaft length, 0.035 dilator, hydrophilic coated, including acce
• 10801741223775: 4F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including acce