DEVICE: AtriClip™ LAA Exclusion System (10840143906381)

Device Identifier (DI) Information

AtriClip™ LAA Exclusion System
ACH245
In Commercial Distribution
A000918
ATRICURE, INC.
10840143906381
GS1

1
006133784 *Terms of Use
AtriClip® FLEX Gilinov-Cosgrove LAA Exclusion System 45
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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
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FDA Product Code

[?]
Product Code Product Code Name
PZX Left Atrial Appendage Clip, Implantable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: more than 20 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 45 Millimeter
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Device Record Status

7a561cdb-544b-4d42-8751-5eb933c21924
January 13, 2023
1
January 05, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30840143906385 1 10840143906381 In Commercial Distribution Box
50840143906389 12 30840143906385 In Commercial Distribution Overshipper
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
866-349-2342
xxx@xxx.xxx
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