Cytology Brush CB-1622

GUDID 10816207020546

Flexible endoscopic cytology brush

ENDO-THERAPEUTICS, INC.

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• Primary Device ID: 10816207020546
• NIH Device Record Key: d73c3bef-810c-4fb0-8b9f-3994b4d20b63
• Commercial Distribution Discontinuation: 2019-11-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cytology Brush
• Version Model Number: CB-1622
• Catalog Number: CB-1622
• 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
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Length: 220 Centimeter
• 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
• 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	00816207020549 [Primary]
GS1	10816207020546 [Package]; Contains: 00816207020549; Package: box [10 Units]; Discontinued: 2019-11-04; Not 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-05
• Device Publish Date: 2016-09-20

On-Brand Devices [Cytology Brush]

• 10816207020546: Flexible endoscopic cytology brush
• 10816207020539: Flexible endoscopic cytology brush
• 10816207020522: Flexible endoscopic cytology brush
• 10816207020515: Flexible endoscopic cytology brush