ARISTA™ AH FlexiTip™ XL

Basic Information

• Brand Name: ARISTA™ AH FlexiTip™ XL
• Primary DI: 00801741044076
• Version / Model: AM0005
• Catalog Number: AM0005
• Company Name: Davol Inc.
• Labeler DUNS: 001191048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2c11829c-3b74-48ed-a3df-e7962b7a6ac7

Device Description

Arista AH FlexiTip XL Applicator

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LMG	Agent, absorbable hemostatic, non-collagen based	General, Plastic Surgery	878.4490	3

GMDN Terms

Code	Name	Definition	Implantable	Status
60502	Atomizing surgical topical solution applicator	A sterile, hand-held manual surgical device intended to be used to apply a topical solution (e.g., medication) in the form of a mist/spray onto the mucosal or serosal surface of an exposed surgical site [e.g., during ear/nose/throat (ENT) or laparoscopic surgery]. It consists of a syringe connected to a cannula (e.g., via a Luer-lock), and contains a built-in atomizer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10801741044073	GS1	CA	10	In Commercial Distribution
Primary	00801741044076	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	38	Centimeter