Pediatric Grooved Tip Sucker

Basic Information

• Brand Name: Pediatric Grooved Tip Sucker
• Primary DI: B0662010360000
• Version / Model: 201036-000
• Catalog Number: 201036-000
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 6
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 2ce9b764-42dd-4afb-b32e-fa5fac4b8109
• Distribution End Date: 2023-06-20

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): No
• 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
60793	Surgical irrigation/aspiration handpiece, single-use	A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B0662010360006	HIBCC	Case	100	Not in Commercial Distribution	2023-06-20
Primary	B0662010360000	HIBCC
Package	B0662010360005	HIBCC	Partial Case	75	Not in Commercial Distribution	2023-06-20
Package	B0662010360004	HIBCC	Partial Case	50	Not in Commercial Distribution	2023-06-20
Package	B0662010360003	HIBCC	Inner Carton	25	Not in Commercial Distribution	2023-06-20

Premarket Submissions

Submission Number	Supplement Number
K801400	000