| Primary Device ID | 00860000270403 |
| NIH Device Record Key | 26d4415b-c673-4313-a63c-86e58b51873a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nella VuSleeve |
| Version Model Number | VS000 |
| Company DUNS | 116951931 |
| Company Name | CEEK WOMEN'S HEALTH |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com | |
| Phone | 3309909065 |
| mlalli@ceekwomenshealth.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000270403 [Primary] |
| GS1 | 10860000270400 [Package] Package: box of 20 [20 Units] In Commercial Distribution |
| HIB | Speculum, Vaginal, Nonmetal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-04 |
| Device Publish Date | 2020-08-27 |