JustRight 5mm Stapler JR-ST25-2.0

GUDID 10865163000109

JustRight 5mm Stapler-single

JUSTRIGHT SURGICAL, LLC

Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting

• Primary Device ID: 10865163000109
• NIH Device Record Key: ed8c4232-8539-422f-a89b-915988a2b740
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JustRight 5mm Stapler
• Version Model Number: JR-ST25-2.0
• Catalog Number: JR-ST25-2.0
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00865163000102 [Primary]
GS1	10865163000109 [Package]; Contains: 00865163000102; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132472

FDA Product Code

• GAG: STAPLER, SURGICAL

Sterilization

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

[10865163000109]

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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