EndoTBrush Cytology Brush ET1427

GUDID 10816207021758

Endoscopic cytology brush

ENDO-THERAPEUTICS, INC.

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 10816207021758
• NIH Device Record Key: 4f28b0e8-f758-4e3d-80e6-def81ebde5c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoTBrush Cytology Brush
• Version Model Number: ET1427
• Catalog Number: ET1427
• Company DUNS: 825239189
• Company Name: ENDO-THERAPEUTICS, 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

Customer Support Contacts

• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com
• Phone: 844-400-3636
• Email: customerservice@endotherapeutics.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 230 Centimeter
• Outer Diameter: 2.4 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816207021751 [Primary]
GS1	10816207021758 [Package]; Contains: 00816207021751; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800966

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: 2024-04-26
• Device Publish Date: 2024-04-18

On-Brand Devices [EndoTBrush Cytology Brush]

• 10816207020164: Endoscopic cytology brush
• 10816207020157: Endoscopic cytology brush
• 10816207020140: Endoscopic cytology brush
• 10816207020133: Endoscopic cytology brush
• 10816207021758: Endoscopic cytology brush