| Primary Device ID | 10627825007518 |
| NIH Device Record Key | 2395dce3-3cef-4b07-b3f9-a291c1fddbcb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 2-lumen Cystometry Pack |
| Version Model Number | 9021T1091 |
| 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 | 00627825007504 [Primary] |
| GS1 | 10627825007518 [Package] Contains: 00627825007504 Package: [25 Units] In Commercial Distribution |
| FEN | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10627825007518]
Ethylene Oxide
[10627825007518]
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 |
| 10627825007570 | with Rectal Split Balloon with Introducer, 6F |
| 10627825007549 | with Rectal Split Balloon, 8F |
| 10627825007518 | with Rectal Split Balloon, 6F |