Suresample, Endometrial Sampler

GUDID GYNX31214

GYNEX CORPORATION

Endometrial biopsy kit

• Primary Device ID: GYNX31214
• NIH Device Record Key: 5f2e8cc7-5e0f-4966-9e0f-0c810d19670f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suresample, Endometrial Sampler
• Version Model Number: 3121
• Company DUNS: 012997685
• Company Name: GYNEX CORPORATION
• Device Count: 100
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	GYNX31050 [Unit of Use]
HIBCC	GYNX31214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001555

FDA Product Code

• HHK: Curette, Suction, Endometrial (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-10

On-Brand Devices [Suresample, Endometrial Sampler]

• GYNX31214: 3121
• GYNX31203: 3120
• GYNX31151: 3115
• GYNX31051: 3105