Infinity 00711499

GUDID 10724995183773

The disposable Infinity Cytology Brush is used to retrieve cytological cell samples in the gastrointestinal tract.

US Endoscopy

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 10724995183773
• NIH Device Record Key: d3a34850-7512-4b59-9d34-afabcad9edb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity
• Version Model Number: 00711499
• Catalog Number: 00711499
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter
• Length: 230 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• 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	00724995183776 [Primary]
GS1	00816765012185 [Previous]
GS1	10724995183773 [Package]; Contains: 00724995183776; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924104

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: 2020-04-09
• Device Publish Date: 2020-04-01

On-Brand Devices [Infinity]

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• 10816765012182: The disposable Infinity Cytology Brush is used to retrieve cytological cell samples in the gastr
• 10816765011789: The disposable Infinity ERCP sampling device is used to retrieve cytological cell samples in the
• 10724995184046: The disposable Infinity ERCP sampling device is used to retrieve cytological cell samples in the
• 10724995184039: The disposable Infinity ERCP sampling device is used to retrieve cytological cell samples in the
• 10724995183773: The disposable Infinity Cytology Brush is used to retrieve cytological cell samples in the gastr