FDA.reportPublic FDA data

Gynex SpecuLume EZ

Primary DI
00816908010795
Brand
Gynex SpecuLume EZ
Company
CYALUME TECHNOLOGIES, INC.
Model
7-64551
Catalog number
7-64551
Device description
Self Illuminated Vaginal Speculum (Small, Screw Closure, Elevating)
Published
2019-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
10816908010792PackageGS125Not in Commercial Distribution
00816908010795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081690801079210816908010792
00816908010795008169080107958169080107950816908010795

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, single-useA hand-held manual instrument intended to dilate 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 to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit90 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-888-733-4034info@cyalumemed.com

Regulatory Flags#

DUNS number
154779748
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816908010627SpecuLume7-342227-342222017-04-05
00816908010634SpecuLume7-342217-342212017-04-05
00816908010641SpecuLume7-342237-342232017-04-05
00816908010689OnLite7-1028W7-1028W2017-04-05
00816908010696OnLite7-1028B7-1028B2017-04-05
00816908010702CareSpec7-564417-564412018-03-01
00816908010719CareSpec7-564427-564422018-03-01
00816908010726CareSpec7-564437-564432018-03-01
00816908010733SpecuLume EZ7-675527-675522018-10-23
00816908010757SpecuLume EZ7-675537-675532018-10-23
00816908010818Gynex SpecuLume EZ7-645537-645532019-10-16
00816908010825SpecuLume7-515517-515512021-11-15
00816908010832SpecuLume7-515527-515522021-11-15
00816908010849SpecuLume7-515537-515532021-11-15
00816908010801Gynex SpecuLume EZ7-645527-645522019-10-16
00816908010740SpecuLume EZ7-675517-675512018-10-23
10816908010822SpecuLume7-515517-515512021-11-15
10816908010839SpecuLume7-515527-515522021-11-15
10816908010846SpecuLume7-515537-515532021-11-15
00816908010658ViaLume7-453317-453312017-04-05

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
00630094298023Bioseal 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
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