| Primary Device ID | 00817688021940 |
| NIH Device Record Key | 5482f08f-8c69-45c3-88ee-ba0f8a7a8f25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ESU Shroud |
| Version Model Number | ICM-000-0175 |
| Company DUNS | 616182895 |
| Company Name | I.C. MEDICAL, INC. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817688021148 [Unit of Use] |
| GS1 | 00817688021940 [Primary] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
[00817688021940]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-08 |
| Device Publish Date | 2016-09-24 |
| 00817688022404 | ICM-000-0560 |
| 00817688021995 | ICM-000-0543 |
| 00817688021988 | ICM-000-0542 |
| 00817688021971 | ICM-000-0449 |
| 00817688021940 | ICM-000-0175 |
| 00817688021933 | ICM-000-0101 |
| 00817688021209 | ICM-000-0357 |
| 00817688021186 | ICM-000-0301E |
| 00817688021162 | ICM-000-0226 |
| 00817688021124 | ICM-000-0169 |
| 00817688021100 | ICM-000-0166 |
| 00817688021087 | ICM-000-0148 |
| 00817688021063 | ICM-000-0017 |
| 00817688022497 | ICM-000-0568 |
| 00817688022657 | ESU Shroud, Short Tip, 1’ Tube, Sterile |