FDA.reportPublic FDA data

SpecuLume

Primary DI
10816908010846
Brand
SpecuLume
Company
CYALUME TECHNOLOGIES, INC.
Model
7-51553
Catalog number
7-51553
Device description
Self Illuminated Vaginal Speculum (Large, Screw Closure)
Published
2021-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10816908010846PackageGS125In Commercial Distribution
20816908010843PackageGS14In Commercial Distribution
00816908010849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081690801084610816908010846
2081690801084320816908010843
00816908010849008169080108498169080108490816908010849

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4637133030carlos@wingplast.se

Regulatory Flags#

DUNS number
154779748
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00816908010795Gynex SpecuLume EZ7-645517-645512019-10-16
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
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
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
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