Laminaria

GUDID GYNX161041

GYNEX CORPORATION

Hygroscopic cervical dilator

• Primary Device ID: GYNX161041
• NIH Device Record Key: 609adc4a-79c1-4cc7-829c-72117d731820
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laminaria
• Version Model Number: 16-104
• Company DUNS: 012997685
• Company Name: GYNEX CORPORATION
• Device Count: 12
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	GYNX161040 [Unit of Use]
HIBCC	GYNX161041 [Primary]

FDA Product Code

• HDY: Dilator, Cervical, Hygroscopic-Laminaria

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: 2017-01-19

On-Brand Devices [Laminaria]

• GYNX161051: 16-105
• GYNX161041: 16-104
• GYNX161031: 16-103