Gynex SpecuLume EZ 7-64553

GUDID 10816908010815

Self Illuminated Vaginal Speculum (Large, Screw Closure, Elevating)

CYALUME TECHNOLOGIES, INC.

Vaginal speculum, single-use
Primary Device ID10816908010815
NIH Device Record Key3af0f2bb-75f6-4e49-8dfc-6e1fab2f4c4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGynex SpecuLume EZ
Version Model Number7-64553
Catalog Number7-64553
Company DUNS154779748
Company NameCYALUME TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-733-4034
Emailinfo@cyalumemed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100816908010818 [Primary]
GS110816908010815 [Package]
Contains: 00816908010818
Package: Box [25 Units]
In Commercial Distribution

FDA Product Code

HIBSpeculum, Vaginal, Nonmetal
HICSpeculum, Vaginal, Nonmetal, Fiberoptic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-03
Device Publish Date2019-10-16

On-Brand Devices [Gynex SpecuLume EZ]

10816908010815Self Illuminated Vaginal Speculum (Large, Screw Closure, Elevating)
00816908010801Self Illuminated Vaginal Speculum (Medium, Screw Closure, Elevating)
10816908010792Self Illuminated Vaginal Speculum (Small, Screw Closure, Elevating)

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