Primary Device ID | 00861705000425 |
NIH Device Record Key | 98529778-eafa-434b-8dda-3d72af9f4cd3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Nagare |
Version Model Number | SS8FMB74 |
Company DUNS | 015986592 |
Company Name | KALILA MEDICAL, INC. |
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 | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1-800-888-3786 |
TMCCustomer.admin@terumomedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810591020222 [Previous] |
GS1 | 00861705000425 [Primary] |
DYB | Introducer, Catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-03-05 |
Device Publish Date | 2018-05-29 |
00850021246082 - CrossWise | 2022-02-09 Steerable Transseptal Sheath |
00861705000425 - Nagare | 2020-03-05Steerable Sheath, Bi-Directional |
00861705000425 - Nagare | 2020-03-05 Steerable Sheath, Bi-Directional |
00810591020215 - Vado | 2020-03-05 Steerable Sheath, Unidirectional (140 degrees) |
00810591020222 - Vado | 2020-03-05 Steerable Sheath, Bidirectional |
00810591020239 - Vado | 2020-03-05 Steerable Sheath, Unidirectional (200 degrees) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NAGARE 88380811 not registered Live/Pending |
RAINLIGHT STUDIO LLC 2019-04-11 |
NAGARE 87528834 not registered Live/Pending |
Terumo Kabushiki Kaisha 2017-07-14 |
NAGARE 85813526 not registered Dead/Abandoned |
Robert McGinnis 2013-01-01 |
NAGARE 77704498 3804384 Dead/Cancelled |
price mark 2009-04-01 |