JustRight Generator JR100

GUDID 00865163000133

JustRight Generator 1/case

JUSTRIGHT SURGICAL, LLC

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• Primary Device ID: 00865163000133
• NIH Device Record Key: ab1dc4a1-b021-4772-a72c-159914a77730
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JustRight Generator
• Version Model Number: JR100
• Catalog Number: JR100
• Company DUNS: 025214641
• Company Name: JUSTRIGHT SURGICAL, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(866)683-1743
• Email: customersupport@justrightsurgical.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00865163000133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123662

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-10

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• 10850346007044 - CoolSeal™ Trinity: 2020-10-21 Maryland Laparoscopic Sealer/Divider/Dissector, 37 cm
• 10850346007068 - CoolSeal™ Trinity: 2020-10-21 Maryland Laparoscopic Sealer/Divider/Dissector, 44 cm
• 10850346007099 - CoolSeal™ Mini: 2020-10-21 Maryland Laparoscopic Sealer
• 10865163000109 - JustRight 5mm Stapler: 2019-05-07 JustRight 5mm Stapler-single
• 10865163000116 - JustRight5mm Reload: 2019-05-07 JustRight 5mm Reload - single