| Primary Device ID | 00853615006000 |
| NIH Device Record Key | b51ddef9-d540-448c-abb3-145744b88145 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WomanCare Global Flexible Karman Cannula, 10mm |
| Version Model Number | FC10 |
| Company DUNS | 064730456 |
| Company Name | WOMANCARE GLOBAL TRADING, INC. |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00853615006000 - WomanCare Global Flexible Karman Cannula, 10mm | 2018-03-29A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicators for measuring the depth of the uterus. Cannulae, regardless of size, have a number identifying the size of cannula. The cannulae are color-coded and use adapters that are also color-coded. This is single-use device, sealed into packaging and sterilized. |
| 00853615006000 - WomanCare Global Flexible Karman Cannula, 10mm | 2018-03-29 A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicator |
| 00853615006024 - WomanCare Global Flexible Karman Cannula, 12mm | 2018-03-29 A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicator |
| 00853615006031 - WomanCare Global Flexible Karman Cannula, 4mm | 2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannula feature dots as indicators for mea |
| 00853615006048 - WomanCare Global Flexible Karman Cannula, 5mm | 2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me |
| 00853615006055 - WomanCare Global Flexible Karman Cannula, 6mm | 2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me |
| 00853615006062 - WomanCare Global Flexible Karman Cannula, 7mm | 2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me |
| 00853615006079 - WomanCare Global Flexible Karman Cannula, 8mm | 2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me |
| 00853615006086 - WomanCare Global Flexible Karman Cannula, 9mm | 2018-03-29 A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicator |