| Primary Device ID | 00860000270458 |
| NIH Device Record Key | 3896344e-8d94-4694-a036-fac292b78fb3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nella Single Use |
| Version Model Number | NSRL096 |
| Company DUNS | 116951931 |
| Company Name | CEEK WOMEN'S HEALTH |
| Device Count | 96 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com | |
| Phone | 3158577219 |
| tbennett@ceekwomenshealth.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000270458 [Unit of Use] |
| GS1 | 10860000270455 [Primary] |
| HIB | Speculum, Vaginal, Nonmetal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[00860000270458]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-30 |
| Device Publish Date | 2023-05-22 |