AROSuture Sterile

Basic Information

• Brand Name: AROSuture Sterile
• Primary DI: 10818245020441
• Version / Model: E13A06N-25
• Catalog Number: E13A06N-25
• Company Name: AROS SURGICAL INSTRUMENTS CORPORATION
• Labeler DUNS: 883777989
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2016-11-18
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 886f4d04-4a41-4675-827b-163b8c02d5da

Device Description

AROSuture-Sterile 6-0, 3/8 circle, 17mm, Extra reverse cutting, 10 inches, Box/12

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAR	Suture, nonabsorbable, synthetic, polyamide	General, Plastic Surgery	878.5020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47068	Vascular clamp, single-use	A sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10818245020441	GS1
Unit of Use	00818245020444	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Needle Length 13mm
Device Size Text, specify			Thread Diameter 0.07mm