Galenica

GUDID 20888937010125

Galenica 10 Vaginal Specula • Large

Coopersurgical, Inc.

Vaginal speculum, single-use

• Primary Device ID: 20888937010125
• NIH Device Record Key: 367b5316-1747-49b0-9317-b17323473f89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galenica
• Version Model Number: 8311
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937010125 [Package]; Contains: 50888937010126; Package: [10 Units]; In Commercial Distribution
GS1	40888937010129 [Package]; Package: [24 Units]; In Commercial Distribution
GS1	50888937010126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K841909

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Galenica]

• 20888937010125: Galenica 10 Vaginal Specula • Large
• 40888937010112: Galenica 10 Vaginal Specula • Medium
• 50888937010102: Galenica 10 VAGINAL SPECULA • SMALL
• 40888937012437: Galenica 1 Large Vaginal Speculum
• 40888937012420: Galenica 1 Medium Vaginal Speculum
• 40888937012413: Galenica 1 Small Vaginal Speculum