FDA.reportPublic FDA data

KS-4S koplight S blade

Primary DI
04562231093481
Brand
KS-4S koplight S blade
Company
YASUI CO.,LTD.
Model
KS-4S
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
34562231093482PackageGS112In Commercial Distribution
04562231093481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3456223109348234562231093482
04562231093481045622310934814562231093481

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
Depth59Millimeter
Length113Millimeter
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

Contacts#

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

Regulatory Flags#

DUNS number
694226838
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
34562231093475KS-3S koplight S bladeKS-3S2024-08-19
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
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266950Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266967Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266974Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266981Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
B7683361430Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683363220Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683439140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-24
B7682462200Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-23
B7682461610Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685612810Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685255060Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255120Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257350Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257670Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255190Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685257320Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685612550Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-07-23
B7685661130Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-06-13
B7682460140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30
B7683359530Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30