AccessGUDID - DEVICE: CROMA Electrosurgical Generator (05060359561206)

GUDID

Device Identifier (DI) Information

Brand Name: CROMA Electrosurgical Generator
Version or Model: PRD-EMR-050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRD-EMR-050
Company Name: CREO MEDICAL LIMITED

Primary DI Number: 05060359561206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 733853373 *Terms of Use

Device Description: The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.

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):	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?
63396	Microwave/electrosurgical system generator	An electrically-powered component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
GEI	Electrosurgical, Cutting & Coagulation & Accessories
NEY	System, Ablation, Microwave And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242983	000

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
Handling Environment Atmospheric Pressure: between 69 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 69 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 30 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eb1a2e6d-8ebc-43c2-a192-a15eee9a263c
Public Version Date: February 18, 2025
Public Version Number: 1
DI Record Publish Date: February 10, 2025