DEVICE: AtriClip™ LAA Exclusion System (10840143901362)
Device Identifier (DI) Information
AtriClip™ LAA Exclusion System
LAA050
In Commercial Distribution
A000647
ATRICURE, INC.
LAA050
In Commercial Distribution
A000647
ATRICURE, INC.
AtriClip® Gilinov-Cosgrove LAA Exclusion System 50
Device Characteristics
MR Conditional | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35649 | Ligation clip, metallic |
A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FZP | Clip, Implantable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: more than 20 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 50 Millimeter |
Device Record Status
059bfc2c-1499-4472-8f7e-a230c3a390c1
February 05, 2021
2
January 08, 2021
February 05, 2021
2
January 08, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30840143901472 | 1 | 10840143901362 | In Commercial Distribution | box | |
50840143900530 | 12 | 30840143901472 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-349-2342
xxx@xxx.xxx
xxx@xxx.xxx