| Primary Device ID | 10860000270424 |
| NIH Device Record Key | d7eb014c-15e5-4ccc-9d5a-b90a06f39405 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nella NuSpec |
| Version Model Number | NU001 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000270427 [Primary] |
| GS1 | 10860000270424 [Package] Contains: 00860000270427 Package: box of 10 [10 Units] In Commercial Distribution |
| HIB | Speculum, Vaginal, Nonmetal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant
[10860000270424]
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 | 2020-08-26 |
| Device Publish Date | 2020-08-18 |