Prima Series® Vaginal Speculum
GUDID 00888937000115
Prima Series® Vaginal Speculum • Large
Coopersurgical, Inc.
Vaginal speculum, reusable| Primary Device ID | 00888937000115 |
| NIH Device Record Key | e5824d54-6ce1-46a8-ac4f-04a818fe1950 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prima Series® Vaginal Speculum |
| Version Model Number | PSV-2L |
| 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 | 00888937000115 [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 |
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical
[00888937000115]
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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