Disposable Gastrointestinal Cytology Brush

GUDID 00813353010325

Gastrointestinal Cytology Brush 3.0mm Brush Diameter x 2.3mm Catheter Diameter x 160cm Length

Telemed Systems

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 00813353010325
• NIH Device Record Key: 002328af-f552-4285-a97d-52cd5db5a310
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Gastrointestinal Cytology Brush
• Version Model Number: 3008
• Company DUNS: 017939239
• Company Name: Telemed Systems
• 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: true
• Expiration Date: true
• 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
GS1	00813353010325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901435

FDA Product Code

• FDX: Endoscopic Cytology Brush

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-01
• Device Publish Date: 2023-08-24

On-Brand Devices [Disposable Gastrointestinal Cytology Brush]

• 00813353010349: Gastrointestinal Cytology Brush 3.0mm Brush Diameter x 2.3mm Catheter Diameter x 230cm Length
• 00813353010332: Gastrointestinal Cytology Brush 3.0mm Brush Diameter x 2.3mm Catheter Diameter x 200cm Length
• 00813353010325: Gastrointestinal Cytology Brush 3.0mm Brush Diameter x 2.3mm Catheter Diameter x 160cm Length
• 00813353010318: Gastrointestinal Cytology Brush 3.0mm Brush Diameter x 1.8mm Catheter Diameter x 230cm Length
• 00813353010301: Gastrointestinal Cytology Brush 3.0mm Brush Diameter x 1.8mm Catheter Diameter x 200cm Length
• 00813353010295: Gastrointestinal Cytology Brush 3.0mm Brush Diameter x 1.8mm Catheter Diameter x 160cm Length