Halo One™ Thin-Walled Guiding Sheath HLO61035
GUDID 00801741161957
Halo One 6F guiding sheath diameter, 10 cm shaft length, including 035 Dilator
CLEARSTREAM TECHNOLOGIES LIMITED
Vascular guide-catheter, single-use| Primary Device ID | 00801741161957 |
| NIH Device Record Key | 91c9f744-7b2f-4b10-a877-8935f9da67a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Halo One™ Thin-Walled Guiding Sheath |
| Version Model Number | HLO61035 |
| Catalog Number | HLO61035 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741161957 [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 |
Trademark Results [Halo One]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HALO ONE 90021347 not registered Live/Pending |
Sauna Works Inc. 2020-06-25 |
 HALO ONE 88048816 not registered Live/Pending |
C. R. Bard, Inc. 2018-07-23 |
 HALO ONE 86715511 not registered Dead/Abandoned |
C. R. Bard, Inc. 2015-08-05 |
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