Halo One™ Thin-Walled Guiding Sheath

Basic Information

• Brand Name: Halo One™ Thin-Walled Guiding Sheath
• Primary DI: 00801741161827
• Version / Model: HLO41035F
• Catalog Number: HLO41035F
• Company Name: CLEARSTREAM TECHNOLOGIES LIMITED
• Labeler DUNS: 989214291
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-27
• Public Version: 4
• Public Version Date: 2022-05-17
• Public Version Status: Update
• Public Device Record Key: a3d0aff8-8bb9-456a-8d13-aa5e9a88f24d

Device Description

4F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of five

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741161827	GS1
Package	10801741161824	GS1	BX	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K192313	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Shaft Length, 10cm
Device Size Text, specify			Dilator, 035"
Device Size Text, specify			Inner Diameter, 4F