Halo One™ Thin-Walled Guiding Sheath HLO44535

GUDID 00801741161841

Halo One 4F guiding sheath diameter, 45 cm shaft length, including 035 Dilator with hydrophilic coating

CLEARSTREAM TECHNOLOGIES LIMITED

Vascular guide-catheter, single-use
Primary Device ID00801741161841
NIH Device Record Key83b1ef44-e34e-412c-bcd1-716e296b99c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHalo One™ Thin-Walled Guiding Sheath
Version Model NumberHLO44535
Catalog NumberHLO44535
Company DUNS989214291
Company NameCLEARSTREAM TECHNOLOGIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+1(908)277-8000
Emailmedical.services@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741161841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-05
Device Publish Date2020-04-27

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

10801741129695Halo One Thin-Walled Guiding Sheath 5F x 10cm
00801741111549Halo One Thin-Walled Guiding Sheath 5F x 45cm
00801741111525Halo One Thin-Walled Guiding Sheath 5F x 90cm
00801741161964Halo One 6F guiding sheath diameter, 10 cm shaft length, including 035 Dilator Multipack of five
00801741161902Halo One 5F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of fiv
00801741161896Halo One 5F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of fiv
008017411618274F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of five
008017411618104F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of five
10801741184878Halo One 6F guiding sheath diameter, 25 cm shaft length, 035 Dilator with hydrophilic coating
10801741184861Halo One 6F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic c
10801741184854Halo One 5F guiding sheath diameter, 25 cm shaft length, including 035 Dilator with hydrophilic
10801741184847Halo One 5F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic c
10801741184830Halo One 5F guiding sheath diameter,10 cm shaft length, including 018 Dilator with hydrophilic c
10801741184823Halo One 4F guiding sheath diameter,25 cm shaft length, including 035 Dilator with hydrophilic c
10801741184816Halo One 4F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic c
10801741184809Halo One 4F guiding sheath diameter,10 cm shaft length, including 018 Dilator with hydrophilic c
00801741161971Halo One 6F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
00801741161957Halo One 6F guiding sheath diameter, 10 cm shaft length, including 035 Dilator
00801741161940Halo One 5F guiding sheath diameter, 90 cm shaft length, including 035 Dilator with hydrophilic
00801741161933Halo One 5F guiding sheath diameter, 70 cm shaft length, including 035 Dilator with hydrophilic
00801741161926Halo One 5F guiding sheath diameter, 45 cm shaft length, including 035 Dilator with hydrophilic
00801741161919Halo One 5F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
00801741161889Halo One 5F guiding sheath diameter, 10 cm shaft length, including 035 Dilator
00801741161872Halo One 5F guiding sheath diameter, 10 cm shaft length, including 018 Dilator
00801741161865Halo One 4F guiding sheath diameter, 90 cm shaft length, including 035 Dilator with hydrophilic
00801741161858Halo One 4F guiding sheath diameter, 70 cm shaft length, including 035 Dilator with hydrophilic
00801741161841Halo One 4F guiding sheath diameter, 45 cm shaft length, including 035 Dilator with hydrophilic
008017411618344F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
008017411618034F guiding sheath diameter, 10 cm shaft length, including 035 Dilator
008017411617974F guiding sheath diameter, 10 cm shaft length, including 018 Dilator
00801741184871Halo One 6F guiding sheath diameter, 25 cm shaft length, 035 Dilator with hydrophilic coating
00801741184857Halo One 5F guiding sheath diameter, 25 cm shaft length, including 035 Dilator with hydrophilic
00801741184826Halo One 4F guiding sheath diameter,25 cm shaft length, including 035 Dilator with hydrophilic c

Trademark Results [Halo One]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HALO ONE
HALO ONE
90021347 not registered Live/Pending
Sauna Works Inc.
2020-06-25
HALO ONE
HALO ONE
88048816 not registered Live/Pending
C. R. Bard, Inc.
2018-07-23
HALO ONE
HALO ONE
86715511 not registered Dead/Abandoned
C. R. Bard, Inc.
2015-08-05

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