FDA UDI
In Commercial Distribution
🇺🇸 United States
KG-1 koplight light handle
DI: 04562231091074
·
Model: KG-1
·
YASUI CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KG-1 koplight light handle
- Primary DI
- 04562231091074
- Version / Model
- KG-1
- Company Name
- YASUI CO.,LTD.
- Labeler DUNS
- 694226838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-19
- Public Version
- 2
- Public Version Date
- 2025-09-05
- Public Version Status
- Update
- Public Device Record Key
- 6bd0df25-a770-403a-93aa-3233f4bc6c2f
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Hydrogen Peroxide, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04562231091074 | GS1 |
Customer Contacts
- Phone
- +81982637111
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 15.0 | Millimeter | |
| Length | 155.0 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid high humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid ultraviolet light