| Primary Device ID | 20607915129365 |
| NIH Device Record Key | 17f37576-a3aa-46ea-b5ba-31ede0e9d25e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KIT KE018 COLEC1 |
| Version Model Number | GK209 |
| Company DUNS | 187129135 |
| Company Name | APPLIED MEDICAL RESOURCES CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20607915129365 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2015-10-09 |
| 10607915140325 - Alexis® O Wound Protector-Retractor | 2024-09-04 Wound Retractor and Protector |
| 10607915145528 - Inzii Ripstop Redeployable Retrieval System | 2024-03-27 Redeployable tissue retrieval system with Ripstop nylon bag. |
| 00607915146498 - Suction Irrigation System | 2024-02-09 Probe and Valve with dual bag tubing. |
| 00607915146504 - Suction Irrigation System | 2024-02-09 Valve with dual bag tubing. |
| 10607915140790 - Voyant Maryland Fusion Device with Single-Step Activation | 2023-04-04 Electrosurgical Sealer and Divider handpiece |
| 00607915140809 - Voyant Maryland Fusion Device with Single-Step Activation | 2023-04-04 Voyant Maryland Fusion Device with Single-Step Activation |
| 10607915140813 - Voyant Maryland Fusion Device with Single-Step Activation | 2023-04-04 Electrosurgical Sealer and Divider handpiece |
| 10607915145313 - GelPOINT V-Path | 2023-03-27 Transvaginal Access Platform with Insufflation Stabilization System |