| Primary Device ID | 00607915113247 |
| NIH Device Record Key | ff1cb415-a242-4e62-9409-6a88c2fcb6c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A3218 |
| Version Model Number | A3218 |
| Company DUNS | 187129135 |
| Company Name | APPLIED MEDICAL RESOURCES CORPORATION |
| 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 | true |
| 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 | 1.949.713.8300 |
| contact@appliedmedical.com | |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com | |
| Phone | 1.949.713.8300 |
| contact@appliedmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607915113247 [Primary] |
| DWS | Instruments, Surgical, Cardiovascular |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00607915113247]
Moist Heat or Steam Sterilization
[00607915113247]
Moist Heat or Steam Sterilization
[00607915113247]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-08-21 |
| Device Publish Date | 2016-08-23 |
| 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 |
| 10607915145320 - GelPOINT V-Path | 2023-03-27 Transvaginal Access Platform with Insufflation Stabilization System |