AccuTip

Basic Information

• Brand Name: AccuTip
• Primary DI: 00817781020192
• Version / Model: AT1760T
• Company Name: CLINT PHARMACEUTICALS, INC.
• Labeler DUNS: 609197785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-28
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d805d479-6ebc-436e-a112-158bd78b3548

Device Description

Detachable Wing Epidural Needle

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
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	868.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58293	Epidural needle, non-threaded	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817781020196	GS1	Case	4	In Commercial Distribution
Package	10817781020199	GS1	Inner Carton	25	In Commercial Distribution
Primary	00817781020192	GS1

Device Sizes

Type	Value	Unit	Text
Length	6	Inch
Needle Gauge	17	Gauge