Tis-U-Trap Collection Chamber

GUDID 20888937000270

Flat Filter Design

Coopersurgical, Inc.

Endometrial biopsy kit

• Primary Device ID: 20888937000270
• NIH Device Record Key: bbf24e78-ec2e-4629-88a7-bb1505f07416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tis-U-Trap Collection Chamber
• Version Model Number: MX400FLAT
• 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: true
• 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	00888937000276 [Primary]
GS1	20888937000270 [Package]; Contains: 00888937000276; 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: 2016-08-15

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

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