Primary Device ID | 30840143911921 |
NIH Device Record Key | 7f0dcf02-626b-4874-a7b4-bcc392ea741f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AtriClip® Gillinov-Cosgrove® LAA Exclusion System |
Version Model Number | ACH145 |
Catalog Number | A000690 |
Company DUNS | 006133784 |
Company Name | ATRICURE, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com | |
Phone | 866-449-2342 |
SEhlert@atricure.com |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Length | 45 Millimeter |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10840143906121 [Previous] |
GS1 | 10840143911927 [Primary] |
GS1 | 30840143911921 [Package] Contains: 10840143911927 Package: Box [1 Units] In Commercial Distribution |
GS1 | 50840143911925 [Package] Package: Case [12 Units] In Commercial Distribution |
PZX | Left Atrial Appendage Clip, Implantable |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-26 |
Device Publish Date | 2024-02-16 |
30840143911938 | LAA Exclusion System, ACH150 |
30840143911921 | LAA Exclusion System, ACH145 |
30840143911914 | LAA Exclusion System, ACH140 |
30840143911907 | LAA Exclusion System, ACH135 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ATRICLIP 77367229 3573736 Live/Registered |
AtriCure, Inc. 2008-01-09 |