| Primary Device ID | 24714127863478 |
| NIH Device Record Key | 675ba66f-18ba-4f85-bd56-249d8cb7a909 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CapSure Rip-Stop endo pocket (detachable) |
| Version Model Number | FEPC36100 |
| Company DUNS | 658122465 |
| Company Name | UNIMAX MEDICAL SYSTEMS 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Width | 3 Inch |
| Width | 3 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04714127863474 [Primary] |
| GS1 | 14714127863471 [Package] Contains: 04714127863474 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 24714127863478 [Package] Contains: 14714127863471 Package: Carton [50 Units] In Commercial Distribution |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-17 |
| Device Publish Date | 2017-01-09 |
| 14714127861460 - BluView | 2023-03-17 Cannula_15mm/10cm |
| 14714127861736 - BluView | 2023-03-02 CANNULA ONLY 5-12+MM/70MM |
| 14714127860333 - BluView | 2023-02-13 OPTICAL TROCAR |
| 14714127860364 - BluView | 2023-02-13 CANNULA ONLY 5-12+MM/150MM |
| 14714127860456 - BluView | 2023-02-13 CANNULA ONLY 5-11MM/150MM |
| 14714127860463 - BluView | 2023-02-13 CANNULA ONLY 5-11MM/70MM |
| 14714127863570 - Unimax | 2022-05-11 Detachable endo pocket |
| 14714127868551 - Unimax | 2022-05-11 Closed suction catheter |