Biopsy Brush LBB-95

GUDID 00816207021720

Single Use Biopsy Brush

ENDO-THERAPEUTICS, INC.

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 00816207021720
• NIH Device Record Key: 7737eaa8-53d0-49a6-b622-79daac8a3d83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biopsy Brush
• Version Model Number: LBB-95
• Catalog Number: LBB-95
• Company DUNS: 825239189
• Company Name: ENDO-THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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

• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 95 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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
• 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	00816207021720 [Primary]

FDA Product Code

• GEE: Brush, Biopsy, General & Plastic Surgery

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: 2025-03-06
• Device Publish Date: 2025-02-26

Devices Manufactured by ENDO-THERAPEUTICS, INC.

• 10816207021383 - EndoTBasket: 2025-03-06 Endoscopic retrieval device, small hexagonal basket
• 00816207021720 - Biopsy Brush: 2025-03-06Single Use Biopsy Brush
• 00816207021720 - Biopsy Brush: 2025-03-06 Single Use Biopsy Brush
• 10816207021758 - EndoTBrush Cytology Brush: 2024-04-26 Endoscopic cytology brush
• 10816207021178 - 4 Chamber Polyp Trap: 2023-07-19 Suction system canister, 4 chambers, fixed
• 10816207021253 - AcuJect Flex: 2023-07-19 Endoscopic injection needle
• 10816207021321 - RotoNet: 2023-07-19 Endoscopic Retrieval Net - Mini
• 10816207021338 - RotoNet: 2023-07-19 Endoscopic Retrieval Net - Standard, Esophageal
• 10816207021345 - RotoNet: 2023-07-19 Endoscopic Retrieval Net - Standard, Colonic