JustRight5mm Reload

Basic Information

• Brand Name: JustRight5mm Reload
• Primary DI: 00865163000119
• Version / Model: JR-REL25-2.0
• Catalog Number: JR-REL25-2.0
• Company Name: JUSTRIGHT SURGICAL, LLC
• Labeler DUNS: 025214641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-10
• Public Version: 7
• Public Version Date: 2023-04-20
• Public Version Status: Update
• Public Device Record Key: da5bb40b-e2a5-4464-bd84-8f8e5698812f

Device Description

JustRight 5mm Reload - single

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDW	STAPLE, IMPLANTABLE	General, Plastic Surgery	878.4750	2
GAG	STAPLER, SURGICAL	General Hospital	878.4740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35615	Surgical staple loading unit, non-cutting	A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.	Yes	Active
59871	Endoscopic manual linear cutting stapler, single-use	A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10865163000116	GS1	Case	12	In Commercial Distribution
Primary	00865163000119	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K132472	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Staple height 2 mm
Device Size Text, specify			Shaft diameter 5 mm