Single Spike Infiltration Tubing - ReShape

Basic Information

• Brand Name: Single Spike Infiltration Tubing - ReShape
• Primary DI: 30816989020103
• Version / Model: ITS-10-RS
• Catalog Number: ITS-10-RS
• Company Name: HK SURGICAL INC.
• Labeler DUNS: 106885259
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-31
• Public Version: 2
• Public Version Date: 2020-07-01
• Public Version Status: Update
• Public Device Record Key: d31a5ce6-b30e-4abe-9cd9-ee372d7ec070
• Distribution End Date: 2020-06-29

Device Description

KLEIN INFILTRATION SET

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: Yes
• 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
KGZ	Accessories, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47625	Surgical irrigation/aspiration tubing set	A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	38169890200105	GS1
Primary	30816989020103	GS1
Unit of Use	10816989020109	GS1

Customer Contacts

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