Anesthesia Needle - Atkinson

Basic Information

• Brand Name: Anesthesia Needle - Atkinson
• Primary DI: 00813465010015
• Version / Model: 1023
• Catalog Number: 1023
• Company Name: HURRICANE MEDICAL INC
• Labeler DUNS: 093377724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-01-20
• Public Version: 2
• Public Version Date: 2020-04-07
• Public Version Status: Update
• Public Device Record Key: b5f4c12e-889e-4d07-9bd1-1f068e3f7334

Device Description

For administrating local anesthetic agents prior to ophthalmic surgery.

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: Yes
• 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: Yes
• Sterilization Methods: ["Radiation Sterilization", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813465010015	GS1
Unit of Use	10813465010012	GS1

Device Sizes

Type	Value	Unit	Text
Length	32	Millimeter
Needle Gauge	23	Gauge