SPECULUX 00304

GUDID 15060489400038

Self Illuminated Vaginal Speculum (Small, Screw Closure, with Smoke Tube)

EVEXAR MEDICAL LIMITED

Vaginal speculum, single-use

• Primary Device ID: 15060489400038
• NIH Device Record Key: 2e2af0fa-e093-47b9-9508-5d20f66e40b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPECULUX
• Version Model Number: 31061
• Catalog Number: 00304
• Company DUNS: 739654197
• Company Name: EVEXAR MEDICAL LIMITED
• 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: true
• 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

Customer Support Contacts

• Phone: 999-999-9999
• Email: info@evexar.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060489400031 [Primary]
GS1	15060489400038 [Package]; Contains: 05060489400031; Package: Carton [25 Units]; In Commercial Distribution
GS1	25060489400035 [Package]; Package: Carton [4 Units]; In Commercial Distribution

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal

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: 2018-03-29
• Device Publish Date: 2016-07-05

On-Brand Devices [SPECULUX]

• 25060489400141: Self Illuminated Vaginal Speculum (Large, Ratchet Closure)
• 25060489400134: Self Illuminated Vaginal Speculum (Medium, Ratchet Closure)
• 25060489400127: Self Illuminated Vaginal Speculum (Small, Ratchet Closure)
• 25060489400110: Self Illuminated Vaginal Speculum (Large, Screw Closure)
• 25060489400103: Self Illuminated Vaginal Speculum (Medium, Screw Closure)
• 25060489400097: Self Illuminated Vaginal Speculum (Small, Screw Closure)
• 25060489400080: Self Illuminated Vaginal Speculum (Large, Ratchet Closure, with Smoke Tube)
• 25060489400073: Self Illuminated Vaginal Speculum (Medium, Ratchet Closure, with Smoke Tube)
• 25060489400066: Self Illuminated Vaginal Speculum (Small, Ratchet Closure, with Smoke Tube)
• 25060489400059: Self Illuminated Vaginal Speculum (Large, Screw Closure, with Smoke Tube)
• 25060489400042: Self Illuminated Vaginal Speculum (Medium, Screw Closure, with Smoke Tube)
• 15060489400038: Self Illuminated Vaginal Speculum (Small, Screw Closure, with Smoke Tube)