Prima Series® Vaginal Speculum
GUDID 00888937000078
Prima Series® Vaginal Speculum • Medium
Coopersurgical, Inc.
Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable| Primary Device ID | 00888937000078 |
| NIH Device Record Key | cfce2695-6520-4646-b386-cfc04d9630d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prima Series® Vaginal Speculum |
| Version Model Number | PSV-1L |
| Company DUNS | 801895244 |
| Company Name | Coopersurgical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888937000078 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K951898
FDA Product Code
| HIB | Speculum, Vaginal, Nonmetal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000078]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-28 |
On-Brand Devices [Prima Series® Vaginal Speculum]
| 00888937000115 | Prima Series® Vaginal Speculum • Large |
| 00888937000078 | Prima Series® Vaginal Speculum • Medium |
Trademark Results [Prima Series]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRIMA SERIES 75052230 2036967 Live/Registered |
CooperSurgical, Inc. 1996-02-01 |
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