InnoVoyce LLC KLF-001-600

GUDID 00860004755913

KTP Laser Fiber 600

Innovoyce LLC

General/multiple surgical laser system beam guide, single-use
Primary Device ID00860004755913
NIH Device Record Key41b75b0e-6a7a-4b97-bbb3-b1363785fe0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInnoVoyce LLC
Version Model NumberA
Catalog NumberKLF-001-600
Company DUNS118104468
Company NameInnovoyce LLC
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+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com
Phone+1 617 865 9401
Emailinfo@InnoVoyce.com

Device Dimensions

Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer
Outer Diameter600 Micrometer

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004755913 [Primary]
GS110860004755903 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-20
Device Publish Date2024-07-26

On-Brand Devices [InnoVoyce LLC]

10860004755903KTP Laser Fiber 600
00860004755906KTP Laser Fiber 400
00860004755913KTP Laser Fiber 600

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