FDA.reportPublic FDA data

SpecuLume

Primary DI
20816908010621
Brand
SpecuLume
Company
CYALUME TECHNOLOGIES, INC.
Model
7-34222
Catalog number
7-34222
Device description
Self Illuminated Vaginal Speculum (Medium, Screw Closure)
Published
2017-04-05
Public version status
Update
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
HIBSpeculum, Vaginal, Nonmetal
HICSpeculum, Vaginal, Nonmetal, Fiberoptic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816908010624PackageGS125In Commercial Distribution
20816908010621PackageGS14In Commercial Distribution
00816908010627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081690801062410816908010624
2081690801062120816908010621
00816908010627008169080106278169080106270816908010627

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
1-888-733-4034info@cyalumemed.com

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
10816908010846SpecuLume7-515537-515532021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10860008900347ClearSpecClearspec LLCHIB2025-10-29
10860008900354ClearSpecClearspec LLCHIB2025-10-29
00860008900302ClearSpecClearspec LLCHIB2025-10-29
00860008900319ClearSpecClearspec LLCHIB2025-10-29
00860008900326ClearSpecClearspec LLCHIB2025-10-29
00860008900333ClearSpecClearspec LLCHIB2025-10-29
00860008900340ClearSpecClearspec LLCHIB2025-10-29
00860008900357ClearSpecClearspec LLCHIB2025-10-29
00199536930001BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930018BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930025BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930032BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930049BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930056BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
05010058091450UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091474UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091498UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091535UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091573UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091429UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-05-21
00732094214246Welch Allyn, Inc.WELCH ALLYN, INC.HIB2024-09-10
10860000270462Nella Next Single UseCEEK WOMEN'S HEALTHHIB2024-02-09
10850053289269SURGYCOSurgyco LLCHIB2023-12-15