Insufflation Needle

Basic Information

• Brand Name: Insufflation Needle
• Primary DI: 00817984010655
• Version / Model: 0600-6120-000
• Catalog Number: 0600-6120-000
• Company Name: MECTRA LABS, INC.
• Labeler DUNS: 606939072
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-25
• Public Version: 2
• Public Version Date: 2020-01-13
• Public Version Status: Update
• Public Device Record Key: 26b56629-8bfc-44d0-8bcb-0e0176f7fae7
• Distribution End Date: 2020-01-10

Device Description

Insufflation Needle 120MM

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: Yes
• 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
HIF	INSUFFLATOR, LAPAROSCOPIC	Obstetrics/Gynecology	884.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12750	Spring-loaded pneumoperitoneum needle, single-use	A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817984010652	GS1	Inner pack	10	Not in Commercial Distribution	2020-01-10
Primary	00817984010655	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 115 Degrees Fahrenheit