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 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 00801741223808 [Primary] |
DYB | Introducer, catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-12-22 |
Device Publish Date | 2021-12-14 |
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 |