Articulator 00711803

GUDID 10724995180833

The Articulator injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes.

US Endoscopy

General-purpose endoscopic needle, single-use

• Primary Device ID: 10724995180833
• NIH Device Record Key: 7d16071b-f142-4636-a2cd-a8de4196de7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Articulator
• Version Model Number: 00711803
• Catalog Number: 00711803
• 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: 160 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.5 Millimeter
• Length: 160 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.5 Millimeter
• Length: 160 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.5 Millimeter
• Length: 160 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.5 Millimeter
• Length: 160 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	00724995180836 [Primary]
GS1	00816765011843 [Previous]
GS1	10724995180833 [Package]; Contains: 00724995180836; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971842

FDA Product Code

• FCG: Biopsy needle

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 [Articulator]

• 10816765011888: The Articulator injection needle is a single use, disposable, flexible sheath injection needle u
• 10816765011871: The Articulator enteroscope injection needle is a single use, disposable, flexible sheath inject
• 10816765011864: The Articulator injection needle is a single use, disposable, flexible sheath injection needle u
• 10816765011857: The Articulator injection needle is a single use, disposable, flexible sheath injection needle u
• 10816765011840: The Articulator injection needle is a single use, disposable, flexible sheath injection needle u
• 10724995180871: The Articulator injection needle is a single use, disposable, flexible sheath injection needle u
• 10724995180864: The Articulator enteroscope injection needle is a single use, disposable, flexible sheath inject
• 10724995180857: The Articulator injection needle is a single use, disposable, flexible sheath injection needle u
• 10724995180840: The Articulator injection needle is a single use, disposable, flexible sheath injection needle u
• 10724995180833: The Articulator injection needle is a single use, disposable, flexible sheath injection needle u