| Primary Device ID | 10627825000106 |
| NIH Device Record Key | 4ba1c775-7e18-43cd-932e-b5e99a57a79b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ITA |
| Version Model Number | ITA |
| Company DUNS | 203383526 |
| Company Name | Laborie Medical Technologies Canada ULC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627825000109 [Primary] |
| GS1 | 10627825000106 [Package] Contains: 00627825000109 Package: [25 Units] In Commercial Distribution |
| GS1 | 20627825000103 [Package] Package: [200 Units] In Commercial Distribution |
| FEN | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10627825000106]
Ethylene Oxide
[10627825000106]
Ethylene Oxide
[10627825000106]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-21 |
| 30627825007024 - Extension Set 2 | 2022-07-04 |
| 20627825007294 - Extension Line, 60 cm | 2022-07-04 |
| 20627825007317 - Extension Line, 1500mm | 2022-07-04 |
| 20627825007324 - Extension Line, 15cm | 2022-07-04 |
| 20627825007348 - Extension Line, 150cm Blue | 2022-07-04 |
| 30627825007352 - Extension Line, 150cm Yellow | 2022-07-04 |
| 20627825007034 - Extension Set 3 | 2022-07-04 |
| 30627825007307 - Extension Line, 90 cm | 2022-07-04 |