Halo One™ Thin-Walled Guiding Sheath HLO51035F

GUDID 00801741161902

Halo One 5F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of five

CLEARSTREAM TECHNOLOGIES LIMITED

Vascular guide-catheter, single-use

• Primary Device ID: 00801741161902
• NIH Device Record Key: 69b57381-4da6-468c-9b68-341c9d9a36a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halo One™ Thin-Walled Guiding Sheath
• Version Model Number: HLO51035F
• Catalog Number: HLO51035F
• Company DUNS: 989214291
• Company Name: CLEARSTREAM TECHNOLOGIES LIMITED
• Device Count: 5
• 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(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• Email: medical.services@crbard.com
• Phone: +1(908)277-8000
• 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: +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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741161902 [Unit of Use]
GS1	10801741161909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192313

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: 2020-05-05
• Device Publish Date: 2020-04-27

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

• 10801741129695: Halo One Thin-Walled Guiding Sheath 5F x 10cm
• 00801741111549: Halo One Thin-Walled Guiding Sheath 5F x 45cm
• 00801741111525: Halo One Thin-Walled Guiding Sheath 5F x 90cm
• 00801741161964: Halo One 6F guiding sheath diameter, 10 cm shaft length, including 035 Dilator Multipack of five
• 00801741161902: Halo One 5F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of fiv
• 00801741161896: Halo One 5F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of fiv
• 00801741161827: 4F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of five
• 00801741161810: 4F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of five
• 10801741184878: Halo One 6F guiding sheath diameter, 25 cm shaft length, 035 Dilator with hydrophilic coating
• 10801741184861: Halo One 6F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic c
• 10801741184854: Halo One 5F guiding sheath diameter, 25 cm shaft length, including 035 Dilator with hydrophilic
• 10801741184847: Halo One 5F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic c
• 10801741184830: Halo One 5F guiding sheath diameter,10 cm shaft length, including 018 Dilator with hydrophilic c
• 10801741184823: Halo One 4F guiding sheath diameter,25 cm shaft length, including 035 Dilator with hydrophilic c
• 10801741184816: Halo One 4F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic c
• 10801741184809: Halo One 4F guiding sheath diameter,10 cm shaft length, including 018 Dilator with hydrophilic c
• 00801741161971: Halo One 6F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
• 00801741161957: Halo One 6F guiding sheath diameter, 10 cm shaft length, including 035 Dilator
• 00801741161940: Halo One 5F guiding sheath diameter, 90 cm shaft length, including 035 Dilator with hydrophilic
• 00801741161933: Halo One 5F guiding sheath diameter, 70 cm shaft length, including 035 Dilator with hydrophilic
• 00801741161926: Halo One 5F guiding sheath diameter, 45 cm shaft length, including 035 Dilator with hydrophilic
• 00801741161919: Halo One 5F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
• 00801741161889: Halo One 5F guiding sheath diameter, 10 cm shaft length, including 035 Dilator
• 00801741161872: Halo One 5F guiding sheath diameter, 10 cm shaft length, including 018 Dilator
• 00801741161865: Halo One 4F guiding sheath diameter, 90 cm shaft length, including 035 Dilator with hydrophilic
• 00801741161858: Halo One 4F guiding sheath diameter, 70 cm shaft length, including 035 Dilator with hydrophilic
• 00801741161841: Halo One 4F guiding sheath diameter, 45 cm shaft length, including 035 Dilator with hydrophilic
• 00801741161834: 4F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
• 00801741161803: 4F guiding sheath diameter, 10 cm shaft length, including 035 Dilator
• 00801741161797: 4F guiding sheath diameter, 10 cm shaft length, including 018 Dilator
• 00801741184871: Halo One 6F guiding sheath diameter, 25 cm shaft length, 035 Dilator with hydrophilic coating
• 00801741184857: Halo One 5F guiding sheath diameter, 25 cm shaft length, including 035 Dilator with hydrophilic
• 00801741184826: Halo One 4F guiding sheath diameter,25 cm shaft length, including 035 Dilator with hydrophilic c