KA-1 koplight autoclavable sheath

GUDID 04562231093351

-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.

YASUI CO.,LTD.

Hand-held surgical retractor, single-use
Primary Device ID04562231093351
NIH Device Record Key60c785b3-4fac-4619-adb1-d3a1c1d9ab5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameKA-1 koplight autoclavable sheath
Version Model NumberKA-1
Company DUNS694226838
Company NameYASUI CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com
Phone+81982637111
Emailinfo@yasuico.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid high humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid ultraviolet light

Device Identifiers

Device Issuing AgencyDevice ID
GS104562231093351 [Primary]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


[04562231093351]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-27
Device Publish Date2024-08-19

Devices Manufactured by YASUI CO.,LTD.

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04562231093306 - KP-1 koplight light handle O-ring2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and
04562231093313 - KY-1 koplight light handle finger hook2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and
04562231093320 - KD-1 koplight battery inserter2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and
04562231093351 - KA-1 koplight autoclavable sheath2024-08-27-koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and koplight light handle. -koplight S blade/koplight HT S blade is a surgical retractor, and it retracts incisions and/or wounds to provide access to the operative field. koplight S blade/koplight HT S blade is sterilized single-use. -koplight light handle is an auxiliary surgical light, and it illuminates the operative field with LED light.
04562231093351 - KA-1 koplight autoclavable sheath2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and
04562231093368 - KG-2 koplight light handle (Infrared cut-off model)2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and
34562231093451 - KS-1S koplight S blade2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and
34562231093468 - KS-2S koplight S blade2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and

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