FDA.reportPublic FDA data

Halo One™ Thin-Walled Guiding Sheath

Primary DI
00801741161933
Brand
Halo One™ Thin-Walled Guiding Sheath
Company
CLEARSTREAM TECHNOLOGIES LIMITED
Model
HLO57035
Catalog number
HLO57035
Device description
Halo One 5F guiding sheath diameter, 70 cm shaft length, including 035 Dilator with hydrophilic coating
Published
2020-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192313000Halo One Thin-Walled Guiding SheathC.R. Bard, Inc.2019-12-19DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741161933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741161933008017411619338017411619330801741161933

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA 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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
+353()539237111ENN-Complaints@crbard.com

Regulatory Flags#

DUNS number
989214291
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741129698Halo One™ Thin-Walled Guiding SheathHAL510FHAL510F2016-06-10
00801741184802Halo One™ Thin-Walled Guiding SheathHLO41018FHHLO41018FH2020-04-27
00801741184819Halo One™ Thin-Walled Guiding SheathHLO41035FHHLO41035FH2020-04-27
00801741184833Halo One™ Thin-Walled Guiding SheathHLO51018FHHLO51018FH2020-04-27
00801741184840Halo One™ Thin-Walled Guiding SheathHLO51035FHHLO51035FH2020-04-27
00801741184864Halo One™ Thin-Walled Guiding SheathHLO61035FHHLO61035FH2020-04-27
00801741219139Halo One Thin-Walled Guiding SheathHLO61018FHHLO61018FH2021-11-15
00801741223778Halo One Thin-Walled Guiding SheathHLO41018FHKHLO41018FHK2021-12-14
00801741223785Halo One Thin-Walled Guiding SheathHLO41035FHKHLO41035FHK2021-12-14
00801741223815Halo One Thin-Walled Guiding SheathHLO51018FHKHLO51018FHK2021-12-14
00801741223822Halo One Thin-Walled Guiding SheathHLO51035FHKHLO51035FHK2021-12-14
00801741223853Halo One Thin-Walled Guiding SheathHLO61035FHKHLO61035FHK2021-12-14
00801741223907Halo One Thin-Walled Guiding SheathHLO61018FHKHLO61018FHK2021-12-14
00801741184826Halo One™ Thin-Walled Guiding SheathHLO42535HHLO42535H2020-04-27
00801741184857Halo One™ Thin-Walled Guiding SheathHLO52535HHLO52535H2020-04-27
00801741184871Halo One™ Thin-Walled Guiding SheathHLO62535HHLO62535H2020-04-27
00801741223792Halo One Thin-Walled Guiding SheathHLO42518HKHLO42518HK2021-12-14
00801741223808Halo One Thin-Walled Guiding SheathHLO42535HKHLO42535HK2021-12-14
00801741223839Halo One Thin-Walled Guiding SheathHLO52518HKHLO52518HK2021-12-14
00801741223846Halo One Thin-Walled Guiding SheathHLO52535HKHLO52535HK2021-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821329003455GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00821329003462GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00733132658855GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659050GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659067GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00850291007475Triever LA Transseptal SheathInari Medical, Inc.DYB2024-04-15
00810123710430ClotTriever SheathInari Medical, Inc.DYB2023-12-15
00733132629985GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2023-05-25
00733132628285GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11
00733132628308GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11
00733132628322GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11