Gynex SpecuLume EZ 7-64552

GUDID 00816908010801

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

CYALUME TECHNOLOGIES, INC.

Vaginal speculum, single-use

• Primary Device ID: 00816908010801
• NIH Device Record Key: f1828336-e23d-4955-8a7c-d49fa0869466
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gynex SpecuLume EZ
• Version Model Number: 7-64552
• Catalog Number: 7-64552
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-733-4034
• Email: info@cyalumemed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816908010801 [Primary]
GS1	10816908010808 [Package]; Package: Box [25 Units]; In Commercial Distribution

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal
• HIC: Speculum, Vaginal, Nonmetal, Fiberoptic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-03
• Device Publish Date: 2019-10-16

On-Brand Devices [Gynex SpecuLume EZ]

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