FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
00630094298023
Brand
Bioseal Inc.
Company
BIOSEAL
Model
KI802/20
Device description
Vaginal Speculum Clear 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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HICSpeculum, vaginal, nonmetal, fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HICSpeculum, Vaginal, Nonmetal, FiberopticObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094298020PackageGS120In Commercial Distribution
00630094298023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009429802010630094298020
00630094298023006300942980236300942980230630094298023

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic vaginal speculumA 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630094198514Bioseal Inc.19851NS/1002023-12-07
00630094171470Bioseal Inc.17147/012023-09-18
00630094017501Bioseal Inc.1750/502023-09-25
10630094481026Bioseal Inc.DURA102/1002025-05-29
10630094481231Bioseal Inc.DURA123/1002025-05-29
10630094483006Bioseal Inc.DURA300/1002025-05-29
10630094485055Bioseal Inc.DURA505/1002025-05-29
10630094485123Bioseal Inc.DURA512/1002025-05-29
10630094487028Bioseal Inc.DURA702/1002025-05-29
10630094487059Bioseal Inc.DURA705/1002025-05-29
10630094487301Bioseal Inc.DURA730/1002025-05-29
10630094489022Bioseal Inc.DURA902/1002025-05-29
00630094481029Bioseal Inc.DURA102/1002025-05-29
00630094481234Bioseal Inc.DURA123/1002025-05-29
00630094483009Bioseal Inc.DURA300/1002025-05-29
00630094485058Bioseal Inc.DURA505/1002025-05-29
00630094485126Bioseal Inc.DURA512/1002025-05-29
00630094487021Bioseal Inc.DURA702/1002025-05-29
00630094487052Bioseal Inc.DURA705/1002025-05-29
00630094487304Bioseal Inc.DURA730/1002025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816908010825SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2021-11-15
00816908010832SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2021-11-15
00816908010849SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2021-11-15
10816908010822SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2021-11-15
10816908010839SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2021-11-15
10816908010846SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2021-11-15
00630094298016Bioseal Inc.BIOSEALHIC2020-01-28
00630094298054Bioseal Inc.BIOSEALHIC2020-01-28
00630094298078Bioseal Inc.BIOSEALHIC2020-01-28
00630094689012Bioseal Inc.BIOSEALHIC2020-01-28
10630094298013Bioseal Inc.BIOSEALHIC2020-01-28
10630094298020Bioseal Inc.BIOSEALHIC2020-01-28
10630094298051Bioseal Inc.BIOSEALHIC2020-01-28
10630094298075Bioseal Inc.BIOSEALHIC2020-01-28
10630094689019Bioseal Inc.BIOSEALHIC2020-01-28
00816908010795Gynex SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2019-10-16
00816908010818Gynex SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2019-10-16
10816908010792Gynex SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2019-10-16
00816908010801Gynex SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2019-10-16
10816908010815Gynex SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2019-10-16
00816908010733SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2018-10-23
00816908010757SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2018-10-23
20816908010737SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2018-10-23
00816908010740SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2018-10-23
20816908010751SpecuLume EZCYALUME TECHNOLOGIES, INC.HIC2018-10-23
00816908010627SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2017-04-05
00816908010634SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2017-04-05
00816908010641SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2017-04-05
20816908010621SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2017-04-05
20816908010638SpecuLumeCYALUME TECHNOLOGIES, INC.HIC2017-04-05