AtriClip® Gillinov-Cosgrove LAA Exclusion System A000644
GUDID 30840143911860
LAA Exclusion System, LAAØ35
ATRICURE, INC.
Ligation clip, metallic| Primary Device ID | 30840143911860 |
| NIH Device Record Key | 52e084cb-acbd-4b68-b93e-8b3a99978dd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AtriClip® Gillinov-Cosgrove LAA Exclusion System |
| Version Model Number | LAA035 |
| Catalog Number | A000644 |
| 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 |
Customer Support Contacts
| 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 |
Device Dimensions
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
| Length | 35 Millimeter |
Operating and Storage Conditions
| 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 |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840143906725 [Previous] |
| GS1 | 10840143911866 [Primary] |
| GS1 | 30840143911860 [Package] Contains: 10840143911866 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 50840143911864 [Package] Package: Case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233407
FDA Product Code
| PZX | Left Atrial Appendage Clip, Implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-26 |
| Device Publish Date | 2024-02-16 |
On-Brand Devices [AtriClip® Gillinov-Cosgrove LAA Exclusion System]
| 30840143911891 | LAA Exclusion System, LAAØ50 |
| 30840143911884 | LAA Exclusion System, LAAØ45 |
| 30840143911877 | LAA Exclusion System, LAAØ40 |
| 30840143911860 | LAA Exclusion System, LAAØ35 |
Trademark Results [AtriClip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ATRICLIP 77367229 3573736 Live/Registered |
AtriCure, Inc. 2008-01-09 |
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