Guardian VAGINAL RETRACTOR™

GUDID 00888937013184

Guardian VAGINAL RETRACTOR™ Use for Vaginal Inspection and Repair of Episiotomy and Vaginal Laceration

Coopersurgical, Inc.

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• Primary Device ID: 00888937013184
• NIH Device Record Key: 829529e0-092f-401a-90e8-0d0ad2e59125
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian VAGINAL RETRACTOR™
• Version Model Number: 64-330
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937013184 [Primary]
GS1	20888937013188 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• KOH: Instrument, Manual, General Obstetric-Gynecologic

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: 2018-12-27
• Device Publish Date: 2018-11-26

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