HEX HANDLE DEBRIDEMENT SUCKER

Basic Information

• Brand Name: HEX HANDLE DEBRIDEMENT SUCKER
• Primary DI: B0662011640000
• Version / Model: 201164-000
• Catalog Number: 201164-000
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 6
• Public Version Date: 2023-06-20
• Public Version Status: Update
• Public Device Record Key: 483aca57-9ba9-45b1-8d53-f55d63c3a143

Device Description

A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.

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: Yes
• 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
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	870.4420	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63649	General-purpose surgical suction system, vacuum	An assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B0662011640006	HIBCC	Case	100	In Commercial Distribution
Primary	B0662011640000	HIBCC
Package	B0662011640005	HIBCC	Partial Case	75	In Commercial Distribution
Package	B0662011640004	HIBCC	Partial Case	50	In Commercial Distribution
Package	B0662011640003	HIBCC	Inner Carton	25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K801400	000