Single Use Electrosurgical Knife KD-655

GUDID 14953170405621

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID14953170405621
NIH Device Record Keya427b291-916e-4b90-8d98-157c2ef329b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use Electrosurgical Knife KD-655
Version Model NumberKD-655L
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170405624 [Primary]
GS114953170405621 [Package]
Contains: 04953170405624
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNSUnit, electrosurgical, endoscopic (with or without accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-21
Device Publish Date2017-12-19

On-Brand Devices [Single Use Electrosurgical Knife KD-655]

14953170405645KD-655U
14953170405638KD-655Q
14953170405621KD-655L
14953170377539KD-655U
14953170377515KD-655Q
14953170377485KD-655L

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