ELRA Electrode

GUDID 28809306762362

The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.

STARMED CO.,LTD

Endoscopic electrosurgical electrode, bipolar, single-use
Primary Device ID28809306762362
NIH Device Record Key03a59b4f-8ba7-4311-acff-7d4069464a67
Commercial Distribution StatusIn Commercial Distribution
Brand NameELRA Electrode
Version Model Number7-2B22S
Company DUNS694699723
Company NameSTARMED CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82318163546
Emailinquiry@starmed4u.com

Device Dimensions

Shaft Length40 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809306762368 [Primary]
GS118809306762365 [Package]
Contains: 08809306762368
Package: Carton [5 Units]
In Commercial Distribution
GS128809306762362 [Package]
Contains: 08809306762368
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-29
Device Publish Date2019-04-19

On-Brand Devices [ELRA Electrode]

28809306762416The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
18809306762402The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
28809306762393The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
28809306762386The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
28809306762379The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
28809306762362The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
28809306762355The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
28809306762348The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
088099222606997-4B33L
088099222606827-4B33S
088099222606757-4B18L
088099222606687-4B18S
088099222606517-2B22L
088099222606447-2B22S
088099222606207-2B11S

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