AccessGUDID - DEVICE: AtriClip® FLEX-Mini™ LAA Exclusion System (10840143911804)

GUDID

Device Identifier (DI) Information

Brand Name: AtriClip® FLEX-Mini™ LAA Exclusion System
Version or Model: ACHM50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A001406
Company Name: ATRICURE, INC.

Primary DI Number: 10840143911804
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use

Device Description: LAA Exclusion System, ACHM50

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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
PZX	Left Atrial Appendage Clip, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234125	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 50 Millimeter

Device Record Status

Public Device Record Key: aa5284c8-58c4-4c77-9b4a-411afaf6c4dd
Public Version Date: September 09, 2024
Public Version Number: 1
DI Record Publish Date: August 30, 2024