SpecuLume EZ 7-67553

GUDID 20816908010751

Vaginal speculum, single-use

Primary Device ID	20816908010751
NIH Device Record Key	b18b2dcb-3ff9-4139-91c6-9adb26a036df
Commercial Distribution Status	In Commercial Distribution
Brand Name	SpecuLume EZ
Version Model Number	7-67553
Catalog Number	7-67553
Company DUNS	154779748
Company Name	CYALUME TECHNOLOGIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature

Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00816908010757 [Primary]
GS1	10816908010754 [Package] Contains: 00816908010757 Package: Inner Pack [25 Units] In Commercial Distribution
GS1	20816908010751 [Package] Contains: 00816908010757 Package: Case [4 Units] In Commercial Distribution

HIB	Speculum, Vaginal, Nonmetal
HIC	Speculum, Vaginal, Nonmetal, Fiberoptic

Steralize Prior To Use	false
Device Is Sterile	false

20816908010751	Self Illuminated Vaginal Speculum (Large, Screw Closure)
00816908010740	Self Illuminated Vaginal Speculum (Small, Screw Closure)
20816908010737	Self Illuminated Vaginal Speculum (Medium, Screw Closure)