Primary Device ID | H965481070 |
NIH Device Record Key | 7b31ccc0-dcfe-4f8d-89e6-7b90e5c63529 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Navylist |
Version Model Number | 48-107 |
Company DUNS | 809699023 |
Company Name | NAVILYST 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(518)795-1676 |
dgreer@angiodynamics.com |
Length | 80 Centimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H965481070 [Primary] |
HIBCC | H965481071 [Package] Package: BOX [10 Units] In Commercial Distribution |
DQX | Wire, guide, catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-01-03 |
Device Publish Date | 2017-08-07 |
H965481080 | GUIDEWIRE, 0.018 X 65CM Ni/Tu |
H965481070 | GUIDEWIRE, 1.5MM J-.035-80-R0SEN-PTFE |
H965481060 | GUIDEWIRE, 1.5MM J-.038-150-ROSEN-PTFE |
H965481050 | GUIDEWIRE, 1.5MM J-.038-80-ROSEN-PTFE |