FDA.reportPublic FDA data

ViaLume

Primary DI
00816908010658
Brand
ViaLume
Company
CYALUME TECHNOLOGIES, INC.
Model
7-45331
Catalog number
7-45331
Device description
Self Illuminated Vaginal Speculum (Small, Screw Closure)
Published
2017-04-05
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
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816908010655PackageGS125Not in Commercial Distribution
20816908010652PackageGS14Not in Commercial Distribution
00816908010658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081690801065510816908010655
2081690801065220816908010652
00816908010658008169080106588169080106580816908010658

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
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
10816908010846SpecuLume7-515537-515532021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930063BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930070BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930087BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930094BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930100BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930117BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00888937027389OfficeSPECCoopersurgical, Inc.HIB2026-08-06
00888937027396HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027402HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027419HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027426ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027433ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027440ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027457ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027464ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027327ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027334ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027341ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027358HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027365HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027372HER-SpecCoopersurgical, Inc.HIB2026-08-05
00860015815705Rosa SpeculumMY VILLAGE INNOVATIONS INC.HIB2026-07-20
20860000270421Nella Next Reusable Vaginal SpeculumCEEK WOMEN'S HEALTHHIB2026-06-25
00860000270496Nella Comfort Kit First Time ExamCEEK WOMEN'S HEALTHHIB2026-05-05
00860000270472Nella Comfort Kit Classic RetailCEEK WOMEN'S HEALTHHIB2026-04-15
00860000270489Nella Comfort Kit Curves RetailCEEK WOMEN'S HEALTHHIB2026-04-15
10860008900309ClearSpecClearspec LLCHIB2025-10-29
10860008900316ClearSpecClearspec LLCHIB2025-10-29
10860008900323ClearSpecClearspec LLCHIB2025-10-29
10860008900330ClearSpecClearspec LLCHIB2025-10-29