AccessGUDID - DEVICE: KG-2-SET koplight light handle set (infrared cut-off model) (04562231093597)

GUDID

Device Identifier (DI) Information

Brand Name: KG-2-SET koplight light handle set (infrared cut-off model)
Version or Model: KG-2-SET
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: YASUI CO.,LTD.

Primary DI Number: 04562231093597
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694226838 *Terms of Use

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. -KG-2-SET koplight light handle set is packed with KG-2 koplight light handle (Infrared cut-off model), KY-1 koplight light handle finger hook, KP-1 koplight light handle O-ring and KD-1 koplight battery inserter.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62562	Hand-held surgical retractor, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Avoid high humidity
Special Storage Condition, Specify: Avoid ultraviolet light

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 15.0 Millimeter
Length: 155.0 Millimeter

Device Record Status

Public Device Record Key: 6ed66862-7db4-4958-8e4a-f6eabf005d95
Public Version Date: August 27, 2024
Public Version Number: 1
DI Record Publish Date: August 19, 2024