Halo One Thin-Walled Guiding Sheath HLO42535HK

GUDID 00801741223808

4F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including access kit.

CLEARSTREAM TECHNOLOGIES LIMITED

Vascular guide-catheter, single-use

Primary Device ID	00801741223808
NIH Device Record Key	8faf3aca-0983-4801-98d7-5278f9cdfbbf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Halo One Thin-Walled Guiding Sheath
Version Model Number	HLO42535HK
Catalog Number	HLO42535HK
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	+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	00801741223808 [Primary]

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	2021-12-22
Device Publish Date	2021-12-14

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