superDimension

GUDID 20884521843179

Cytology Brush

Covidien LP

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 20884521843179
• NIH Device Record Key: 1a25b6b5-68f9-4a36-a353-9ef6c09e32a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: superDimension
• Version Model Number: AKI00100-01
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521843172 [Primary]
GS1	20884521843179 [Package]; Contains: 10884521843172; Package: PACK_OR_INNER_PACK [10 Units]; In Commercial Distribution

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: 2023-07-31
• Device Publish Date: 2023-07-21

On-Brand Devices [superDimension]

• 20884521200514: Pre-Marked Biopsy Forceps
• 20884521200484: Biopsy Forceps
• 20884521198804: Fiducial Marker;3-Band
• 20884521198781: Fiducial Marker;Coil
• 20884521198774: Fiducial Marker;Coil
• 20884521197708: Fiducial Marker;Coil
• 10884521198722: Patient Sensor Patch
• 10884521785861: superDimension Planning Station
• 10884521806153: navigation system console
• 10884521582835: Planning Station
• 10884521545588: Planning Station
• 10884521200364: iLogic inReach;Planning Laptop
• 20884521200477: Aspirating Needle
• 20884521200552: Triple Needle Cytology Brush;15 mm
• 20884521200545: Triple Needle Cytology Brush;10 mm
• 20884521200521: Marker Delivery Kit
• 20884521200507: Pre-marked Aspirating Needle
• 20884521200491: Pre-marked Aspirating Needle
• 20884521809472: Aspirating Needle
• 20884521809519: Pre-marked Aspirating Needle
• 20884521809588: Triple Needle Cytology Brush;15 mm
• 20884521809571: Triple Needle Cytology Brush;10 mm
• 20884521809540: Pre-Marked Biopsy Forceps
• 20884521809526: Pre-marked Aspirating Needle
• 20884521809564: Marker Delivery Kit
• 20884521807973: Patient Sensor Patch
• 10884521747418: v7.2 upgrade kit
• 10884521199989: Navigation System
• 10884521747432: v7.1 Planning Software
• 10884521747425: v7.2 Procedure Software
• 20884521200538: Needle-tipped Cytology Brush; Aspirating Port
• 20884521200460: Cytology Brush
• 20884521198798: Fiducial Marker;2-Band
• 20884521843216: Needle-tipped Cytology Brush Aspirating Port
• 20884521843209: Pre-marked Aspirating Needle
• 20884521843193: Pre-marked Aspirating Needle
• 20884521843186: Aspirating Needle
• 20884521843179: Cytology Brush
• 10884521199996: Navigation System