AccessGUDID - DEVICE: Synergy™ Ablation System (00818354010206)

GUDID

Device Identifier (DI) Information

Brand Name: Synergy™ Ablation System
Version or Model: ASU2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A000019
Company Name: ATRICURE, INC.

Primary DI Number: 00818354010206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use

Device Description: Ablation and Sensing 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":	No
For Single-Use:	No
Prescription Use (Rx):	No
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?
35156	Percutaneous radio-frequency ablation system generator	An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100046	003
P100046	004
P100046	005
P100046	006
P100046	007
P100046	008

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -35 and 54 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 439019f3-d0e1-4690-8ccf-685c8009a6db
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 866-349-2342
Email: xxx@xxx.xxx

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES