Tis-U-Trap Collection Chamber

GUDID 00888937000269

Cone Filter Design

Coopersurgical, Inc.

Endometrial biopsy kit

• Primary Device ID: 00888937000269
• NIH Device Record Key: 1cc4c0d8-6647-41d2-8d21-3367cee438a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tis-U-Trap Collection Chamber
• Version Model Number: MX400CONE
• 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: true
• 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	00888937000269 [Primary]
GS1	20888937000263 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K760264

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: 2016-08-18

On-Brand Devices [Tis-U-Trap Collection Chamber]

• 20888937000270: Flat Filter Design
• 00888937000269: Cone Filter Design