Ultraspec 9153

GUDID 05010058191532

EcoGold Speculum Large Sterile X25

ROBINSON HEALTHCARE LIMITED

Vaginal speculum, single-use

• Primary Device ID: 05010058191532
• NIH Device Record Key: 05efddf5-295b-4c86-8476-68d9c1b8aa11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultraspec
• Version Model Number: 9153
• Catalog Number: 9153
• Company DUNS: 237799775
• Company Name: ROBINSON HEALTHCARE LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com
• Phone: +441909735502
• Email: ASKVCI@vernacare.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05010058091535 [Primary]
GS1	05010058191532 [Package]; Contains: 05010058091535; Package: Box [25 Units]; In Commercial Distribution

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-26
• Device Publish Date: 2025-06-18

On-Brand Devices [Ultraspec]

• 05010058191426: EcoGold Speculum Extra-Small (Sterile Device) - E476 - Grey X30
• 05010058191570: EcoGold Speculum Broad Sterile X25
• 05010058191532: EcoGold Speculum Large Sterile X25
• 05010058191495: EcoGold Speculum Medium-Long Sterile X25
• 05010058191471: EcoGold Speculum Medium Sterile X25
• 05010058191457: EcoGold Speculum Small Sterile X25