| Primary Device ID | 04562231093306 |
| NIH Device Record Key | c7f88794-ac99-4241-92f7-812e73117b5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KP-1 koplight light handle O-ring |
| Version Model Number | KP-1 |
| Company DUNS | 694226838 |
| Company Name | YASUI CO.,LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com | |
| Phone | +81982637111 |
| info@yasuico.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid high humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid ultraviolet light |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04562231093306 [Primary] |
| GAD | Retractor |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-27 |
| Device Publish Date | 2024-08-19 |
| 04562231091074 - KG-1 koplight light handle | 2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and |
| 04562231093306 - KP-1 koplight light handle O-ring | 2024-08-27-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. -This product is a koplight light handle accessory. |
| 04562231093306 - KP-1 koplight light handle O-ring | 2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and |
| 04562231093313 - KY-1 koplight light handle finger hook | 2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and |
| 04562231093320 - KD-1 koplight battery inserter | 2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and |
| 04562231093351 - KA-1 koplight autoclavable sheath | 2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and |
| 04562231093368 - KG-2 koplight light handle (Infrared cut-off model) | 2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and |
| 34562231093451 - KS-1S koplight S blade | 2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and |
| 34562231093468 - KS-2S koplight S blade | 2024-08-27 -koplight Cordless Lighted Retractor is a medical device consisting of two main parts; koplight S blade/koplight HT S blade and |