Nella NuSpec

GUDID 10860000270424

Reusable Vaginal Speculum

CEEK WOMEN'S HEALTH

Vaginal speculum, reusable
Primary Device ID10860000270424
NIH Device Record Keyd7eb014c-15e5-4ccc-9d5a-b90a06f39405
Commercial Distribution StatusIn Commercial Distribution
Brand NameNella NuSpec
Version Model NumberNU001
Company DUNS116951931
Company NameCEEK WOMEN'S HEALTH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3309909065
Emailmlalli@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com
Phone3158577219
Emailtbennett@ceekwomenshealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000270427 [Primary]
GS110860000270424 [Package]
Contains: 00860000270427
Package: box of 10 [10 Units]
In Commercial Distribution

FDA Product Code

HIBSpeculum, Vaginal, Nonmetal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-26
Device Publish Date2020-08-18