JustRight5mm Reload JR-REL25-2.0

GUDID 10865163000116

JustRight 5mm Reload - single

JUSTRIGHT SURGICAL, LLC

Surgical staple loading unit, non-cutting

• Primary Device ID: 10865163000116
• NIH Device Record Key: da5bb40b-e2a5-4464-bd84-8f8e5698812f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JustRight5mm Reload
• Version Model Number: JR-REL25-2.0
• Catalog Number: JR-REL25-2.0
• Company DUNS: 025214641
• Company Name: JUSTRIGHT SURGICAL, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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(866)683-1743
• Email: customersupport@justrightsurgical.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com
• Phone: +1(800)442-9892
• Email: customersupport@hologic.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00865163000119 [Primary]
GS1	10865163000116 [Package]; Contains: 00865163000119; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132472

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

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

[10865163000116]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2015-08-10

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• 10865163000116 - JustRight5mm Reload: 2019-05-07JustRight 5mm Reload - single
• 10865163000116 - JustRight5mm Reload: 2019-05-07 JustRight 5mm Reload - single