SpecuLume EZ

Basic Information

• Brand Name: SpecuLume EZ
• Primary DI: 00816908010740
• Version / Model: 7-67551
• Catalog Number: 7-67551
• Company Name: CYALUME TECHNOLOGIES, INC.
• Labeler DUNS: 154779748
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 4
• Public Version Date: 2023-01-04
• Public Version Status: Update
• Public Device Record Key: 4fb6d4cc-2ab6-4a1b-98c8-5a41cb301ce6
• Distribution End Date: 2023-01-01

Device Description

Self Illuminated Vaginal Speculum (Small, Screw Closure)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIC	Speculum, Vaginal, Nonmetal, Fiberoptic	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37468	Vaginal speculum, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816908010740	GS1
Package	10816908010747	GS1	Inner Pack	25	Not in Commercial Distribution	2023-01-01
Package	20816908010744	GS1	Case	4	Not in Commercial Distribution	2023-01-01

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 90 Degrees Fahrenheit