AccessGUDID - DEVICE: AtriClip™ LAA Exclusion System (00818354014525)

GUDID

Device Identifier (DI) Information

Brand Name: AtriClip™ LAA Exclusion System
Version or Model: ACH245
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A000918
Company Name: ATRICURE, INC.

Primary DI Number: 00818354014525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use

Device Description: AtriClip® FLEX Gilinov-Cosgrove LAA Exclusion System 45

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
FZP	Clip, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: more than 20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 45 Millimeter

Device Record Status

Public Device Record Key: a2ca8176-396c-4b54-bb3a-d7507f9f8b9b
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: October 24, 2015