FDA.reportPublic FDA data

KS-3S koplight S blade

Primary DI
34562231093475
Brand
KS-3S koplight S blade
Company
YASUI CO.,LTD.
Model
KS-3S
Device description
-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.
Published
2024-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34562231093475PackageGS112In Commercial Distribution
04562231093474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3456223109347534562231093475
04562231093474045622310934744562231093474

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, single-useA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth45Millimeter
Length139Millimeter
Width18Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid high humidity
Special Storage Condition, Specify00Avoid ultraviolet light
Special Storage Condition, Specify00Clean place at room temperature
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81982637111info@yasuico.com

Regulatory Flags#

DUNS number
694226838
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04562231093450KS-1S koplight S bladeKS-1S2024-08-19
04562231093467KS-2S koplight S bladeKS-2S2024-08-19
04562231093474KS-3S koplight S bladeKS-3S2024-08-19
04562231093481KS-4S koplight S bladeKS-4S2024-08-19
04562231093498KS-5S koplight S bladeKS-5S2024-08-19
04562231093504KS-4HS koplight HT S bladeKS-4HS2024-08-19
04562231093511KS-5HS koplight HT S bladeKS-5HS2024-08-19
04562231093528KS-6HS koplight HT S bladeKS-6HS2024-08-19
04562231091074KG-1 koplight light handleKG-12024-08-19
04562231093306KP-1 koplight light handle O-ringKP-12024-08-19
04562231093313KY-1 koplight light handle finger hookKY-12024-08-19
04562231093320KD-1 koplight battery inserterKD-12024-08-19
04562231093351KA-1 koplight autoclavable sheathKA-12024-08-19
04562231093368KG-2 koplight light handle (Infrared cut-off model)KG-22024-08-19
04562231093580KG-1-SET koplight light handle setKG-1-SET2024-08-19
04562231093597KG-2-SET koplight light handle set (infrared cut-off model)KG-2-SET2024-08-19
34562231093451KS-1S koplight S bladeKS-1S2024-08-19
34562231093468KS-2S koplight S bladeKS-2S2024-08-19
34562231093482KS-4S koplight S bladeKS-4S2024-08-19
34562231093499KS-5S koplight S bladeKS-5S2024-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841536148640ThompsonThompson Surgical Instruments, Inc.GAD2026-09-20
08800322775561Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775578Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775585Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775592Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775608Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775615Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775622Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775639Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775646Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775653Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775660Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775677Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775684Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775691Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775707Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775714Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776872Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776889Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776896Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776902Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04
00190776428129MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428259MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428266MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428273MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428280MillenniumAvalign Technologies, Inc.GAD2026-08-27