Patel Pipelle

GUDID B296820010

Single unit

TITUS MEDICAL LLC

Endometrial biopsy kit

• Primary Device ID: B296820010
• NIH Device Record Key: 095287c0-0979-4546-8fd1-37d44c32cb10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patel Pipelle
• Version Model Number: 82001
• Company DUNS: 080306309
• Company Name: TITUS MEDICAL LLC
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B296820010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990387

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: 2016-09-16

On-Brand Devices [Patel Pipelle]

• B296820010: Single unit
• B29682000: Case of 25 Units