Primary Device ID | 00814384020192 |
NIH Device Record Key | 6048faf3-b814-425a-b99c-709ae647db21 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Galeo Pro |
Version Model Number | HF |
Catalog Number | 389781 |
Company DUNS | 189689800 |
Company Name | CONCERT MEDICAL, LLC |
Device Count | 5 |
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 | true |
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 |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814384020185 [Unit of Use] |
GS1 | 00814384020192 [Primary] |
DQX | Wire, Guide, 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 | 2018-03-29 |
Device Publish Date | 2016-09-26 |
00814384020352 | Coronary Guidewire |
00814384020338 | Coronary Guidewire |
00814384020314 | Coronary Guidewire |
00814384020291 | Coronary Guidewire |
00814384020277 | Coronary Guidewire |
00814384020253 | Coronary Guidewire |
00814384020239 | Coronary Guidewire |
00814384020215 | Coronary Guidewire |
00814384020192 | Coronary Guidewire |