Primary Device ID | 00817688021971 |
NIH Device Record Key | 5566a3d3-1fbb-4221-8457-9872b9e463b2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ESU Shroud |
Version Model Number | ICM-000-0449 |
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 | 00817688021254 [Unit of Use] |
GS1 | 00817688021971 [Primary] |
GCJ | Laparoscope, General & Plastic Surgery |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
Ethylene Oxide
[00817688021971]
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 |