| Primary Device ID | 00853615006352 |
| NIH Device Record Key | 21a3e6d3-8db9-46c6-87f7-6bdac2b89d24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WomanCare Global Single-Valve Aspirator |
| Version Model Number | SVS-S10 |
| 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 |
| Phone | +1-858-314-4030 |
| customerservice@womancareglobal.org |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Total Volume | 60 Milliliter |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853615006352 [Primary] |
| GS1 | 10853615006359 [Package] Package: Box [10 Units] In Commercial Distribution |
| HHI | System, Abortion, Vacuum |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-17 |
| 00853615006352 | The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe barrel, |
| 00853615006277 | The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe barrel, |