Home GUDID 10630094298013 Bioseal Inc.
Primary DI 10630094298013
Brand Bioseal Inc.
Company BIOSEAL
Model KI801/20
Device description Vaginal Speculum Clear X-Small, Light Source
Published 2020-01-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
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 10630094298013 Package GS1 20 In Commercial Distribution 00630094298016 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 10630094298013 10630094298013 00630094298016 00630094298016 630094298016 0630094298016
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 HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 00630094689012 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