| Primary Device ID | 00817688021407 |
| NIH Device Record Key | 4f274d32-977d-453f-a3b9-c929a4a59d74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Speculum Tubing |
| Version Model Number | ICM-000-0365 |
| Company DUNS | 616182895 |
| Company Name | I.C. MEDICAL, INC. |
| 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 | 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 | 00817688021391 [Primary] |
| GS1 | 00817688021407 [Package] Contains: 00817688021391 Package: [9 Units] In Commercial Distribution |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
Ethylene Oxide
[00817688021407]
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 |
| 00817688021421 | 2195 |
| 00817688021407 | ICM-000-0365 |
| 00817688021384 | ICM-000-0027 |
| 00817688021360 | ICM-000-0021 |
| 00817688022947 | Speculum Tubing, 22mm to 10mm Connector, Sterile |