star RF Electrode 17-15s10F

GUDID 28809306760788

The star 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.

STARMED CO.,LTD

Percutaneous electrosurgical probe, tumour-ablation, monopolar

Primary Device ID	28809306760788
NIH Device Record Key	35900969-60cd-4dfe-9643-a334ed6f6be2
Commercial Distribution Status	In Commercial Distribution
Brand Name	star RF Electrode
Version Model Number	17-15s10F
Catalog Number	17-15s10F
Company DUNS	694699723
Company Name	STARMED CO.,LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+82318163546
Email	inquiry@starmed4u.com
Phone	+82318163546
Email	inquiry@starmed4u.com
Phone	+82318163546
Email	inquiry@starmed4u.com
Phone	+82318163546
Email	inquiry@starmed4u.com
Phone	+82318163546
Email	inquiry@starmed4u.com
Phone	+82318163546
Email	inquiry@starmed4u.com
Phone	+82318163546
Email	inquiry@starmed4u.com

Device Dimensions

Length	15 Centimeter
Needle Gauge	17 Gauge
Length	15 Centimeter
Needle Gauge	17 Gauge
Length	15 Centimeter
Needle Gauge	17 Gauge
Length	15 Centimeter
Needle Gauge	17 Gauge
Length	15 Centimeter
Needle Gauge	17 Gauge
Length	15 Centimeter
Needle Gauge	17 Gauge
Length	15 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809306760784 [Primary]
GS1	18809306760781 [Package] Contains: 08809306760784 Package: Carton [5 Units] In Commercial Distribution
GS1	28809306760788 [Package] Contains: 08809306760784 Package: Carton [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172012

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-04-23
Device Publish Date	2018-03-21

On-Brand Devices [star RF Electrode]

28809306760832	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
28809306760788	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
28809306760559	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
28809306760061	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
28809306760054	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
28809306760047	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
28809306760023	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
28809306760016	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306763669	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760910	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760903	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760880	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760873	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760866	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760682	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760675	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760668	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760637	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760620	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760613	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760033	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306767230	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760583	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760576	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
18809306760569	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in
08809306767349	The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in