AccessGUDID - DEVICE: EUSRA RF Electrode (08809306766625)

GUDID

Device Identifier (DI) Information

Brand Name: EUSRA RF Electrode
Version or Model: 19-10E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STARMED CO.,LTD

Primary DI Number: 08809306766625
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694699723 *Terms of Use

Device Description: The EUSRA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing.

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:	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?
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
JOS	Electrode, Electrosurgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181249	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 Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 19 Gauge

Device Record Status

Public Device Record Key: 9cffd928-926a-4a85-b60c-84d5e967dc67
Public Version Date: December 31, 2018
Public Version Number: 1
DI Record Publish Date: November 28, 2018