INTERA

Basic Information

• Brand Name: INTERA
• Primary DI: 00850014110048
• Version / Model: AP-04013-5
• Catalog Number: AP040135
• Company Name: INTERA ONCOLOGY INC.
• Labeler DUNS: 117070072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-06
• Public Version: 3
• Public Version Date: 2021-11-09
• Public Version Status: Update
• Public Device Record Key: f209d06b-e102-4bf4-967f-70c77e3f3c9f

Device Description

Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 1 3/8" (3.5cm)

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
PTI	Non-Coring (Huber) Needle	General Hospital	880.5570	2

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
Package	10850014110045	GS1		5	In Commercial Distribution
Primary	00850014110048	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211121	000
P890055	073

Device Sizes

Type	Value	Unit	Text
Needle Gauge	20	Gauge
Length	1.375	Inch