AtriClip® FLEX Gillinov-Cosgrove LAA Exclusion System A000918
GUDID 30840143911969
LAA Exclusion System, ACH245
ATRICURE, INC.
Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic| Primary Device ID | 30840143911969 |
| NIH Device Record Key | 606d1190-8167-440b-a4ca-1f57ea7c12c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AtriClip® FLEX Gillinov-Cosgrove LAA Exclusion System |
| Version Model Number | ACH245 |
| Catalog Number | A000918 |
| 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 | 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 |
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 | 10840143906381 [Previous] |
| GS1 | 10840143911965 [Primary] |
| GS1 | 30840143911969 [Package] Contains: 10840143911965 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 50840143911963 [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® FLEX Gillinov-Cosgrove LAA Exclusion System]
| 30840143911976 | LAA Exclusion System, ACH250 |
| 30840143911969 | LAA Exclusion System, ACH245 |
| 30840143911952 | LAA Exclusion System, ACH240 |
| 30840143911945 | LAA Exclusion System, ACH235 |
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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