FDA.reportPublic FDA data

SpecuLume EZ

Primary DI
20816908010737
Brand
SpecuLume EZ
Company
CYALUME TECHNOLOGIES, INC.
Model
7-67552
Catalog number
7-67552
Device description
Self Illuminated Vaginal Speculum (Medium, Screw Closure)
Published
2018-10-23
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
10816908010730PackageGS125In Commercial Distribution
20816908010737PackageGS14In Commercial Distribution
00816908010733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081690801073010816908010730
2081690801073720816908010737
00816908010733008169080107338169080107330816908010733

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

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