Home GUDID 00630094689012 Bioseal Inc.
Primary DI 00630094689012
Brand Bioseal Inc.
Company BIOSEAL
Model KI901/20
Device description Vaginal Speculum Clear w/ Light Wrapped
Published 2020-01-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name HIC Speculum, vaginal, nonmetal, fiberoptic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HIC Speculum, Vaginal, Nonmetal, Fiberoptic Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10630094689019 Package GS1 20 In Commercial Distribution 00630094689012 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10630094689019 10630094689019 00630094689012 00630094689012 630094689012 0630094689012
GMDN Terms# Term, Definition table Term Definition Fibreoptic vaginal speculum A hand-held manual metallic instrument intended to dilate and illuminate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. The device includes an integrated fibreoptic bundle to transmit light from an electric light source to enhance visualization. This is a reusable device.
Regulatory Flags# DUNS number 186968939 Device count 1 DM exempt true Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816908010825 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2021-11-15 00816908010832 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2021-11-15 00816908010849 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2021-11-15 10816908010822 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2021-11-15 10816908010839 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2021-11-15 10816908010846 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2021-11-15 00630094298016 Bioseal Inc. BIOSEAL HIC 2020-01-28 00630094298023 Bioseal Inc. BIOSEAL HIC 2020-01-28 00630094298054 Bioseal Inc. BIOSEAL HIC 2020-01-28 00630094298078 Bioseal Inc. BIOSEAL HIC 2020-01-28 10630094298013 Bioseal Inc. BIOSEAL HIC 2020-01-28 10630094298020 Bioseal Inc. BIOSEAL HIC 2020-01-28 10630094298051 Bioseal Inc. BIOSEAL HIC 2020-01-28 10630094298075 Bioseal Inc. BIOSEAL HIC 2020-01-28 10630094689019 Bioseal Inc. BIOSEAL HIC 2020-01-28 00816908010795 Gynex SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2019-10-16 00816908010818 Gynex SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2019-10-16 10816908010792 Gynex SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2019-10-16 00816908010801 Gynex SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2019-10-16 10816908010815 Gynex SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2019-10-16 00816908010733 SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2018-10-23 00816908010757 SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2018-10-23 20816908010737 SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2018-10-23 00816908010740 SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2018-10-23 20816908010751 SpecuLume EZ CYALUME TECHNOLOGIES, INC. HIC 2018-10-23 00816908010627 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2017-04-05 00816908010634 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2017-04-05 00816908010641 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2017-04-05 20816908010621 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2017-04-05 20816908010638 SpecuLume CYALUME TECHNOLOGIES, INC. HIC 2017-04-05