Rotator 00711120

GUDID 10724995182646

The Rotator snare oval is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy.

US Endoscopy

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 10724995182646
• NIH Device Record Key: 397ec5cb-e7c9-4a91-9343-252bf489466e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotator
• Version Model Number: 00711120
• Catalog Number: 00711120
• 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
• 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
• 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
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Width: 3 Centimeter
• Outer Diameter: 2.4 Millimeter

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
• 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	00724995182649 [Primary]
GS1	00816765011010 [Previous]
GS1	10724995182646 [Package]; Contains: 00724995182649; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924105

FDA Product Code

• FDI: SNARE, FLEXIBLE

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: 2020-03-27
• Device Publish Date: 2020-03-19

On-Brand Devices [Rotator]

• 10816765011024: The Rotator Snare Mini-Oval is an electrosurgical devices used to grasp, dissect and transect ti
• 10816765011017: The Rotator snare oval is an electrosurgical device used to grasp, dissect and transect tissue d
• 10724995182653: The Rotator Snare Mini-Oval is an electrosurgical devices used to grasp, dissect and transect ti
• 10724995182646: The Rotator snare oval is an electrosurgical device used to grasp, dissect and transect tissue d