FDA.reportPublic FDA data

KS-6HS koplight HT S blade

Primary DI
34562231093529
Brand
KS-6HS koplight HT S blade
Company
YASUI CO.,LTD.
Model
KS-6HS
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
34562231093529PackageGS112In Commercial Distribution
04562231093528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3456223109352934562231093529
04562231093528045622310935284562231093528

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
Length122Millimeter
Width25Millimeter

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
34562231093475KS-3S koplight S bladeKS-3S2024-08-19
34562231093482KS-4S koplight S bladeKS-4S2024-08-19

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Primary DI, Brand, Company table
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00190776422264MillenniumAvalign Technologies, Inc.GAD2026-07-31
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00190776422301MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422530MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422547MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422554MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422561MillenniumAvalign Technologies, Inc.GAD2026-07-31
00190776422578MillenniumAvalign Technologies, Inc.GAD2026-07-31
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00810143904949SURGIPROSSurgipros, LLCGAD2026-07-30
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