AccessGUDID - DEVICE: Synergy™ Ablation System (10840143900020)

GUDID

Device Identifier (DI) Information

Brand Name: Synergy™ Ablation System
Version or Model: GPT300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A000437
Company Name: ATRICURE, INC.

Primary DI Number: 10840143900020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use
Previous DI: 00818354010718

Device Description: Glidepath Tape (3-Unit)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
45454	Cardiac ablation system applicator introducer/sizer	A sterile, flexible device that is used to determine the appropriate size of a cardiac tissue ablation system applicator [to determine the appropriate number of transducers (ablation cells) required to treat the target tissue] and/or used to introduce and guide it into position, or used to help fix the applicator in position. It is designed as a highly flexible tubular-like device with markings indicating different applicator sizes and shaped to facilitate introduction into the pericardium, or may be flexible tubes with hooked ends and wires to fasten an applicator. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, Surgical, Instrument

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b63f7220-26d4-4f52-ac04-4a6e22b4fe3e
Public Version Date: January 18, 2021
Public Version Number: 1
DI Record Publish Date: January 08, 2021