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510(k) Data Aggregation
K Number
K203305Device Name
Tiger Reusable Sharps Container
Manufacturer
International Marketing Specialists Inc.
Date Cleared
2021-08-06
(270 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
International Marketing Specialists Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.
Device Description
Tiger Reusable Sharps Containers are of injection-molded polypropylene plastic, designed for reusable by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture-resistant, leak-resistant on the sides and bottom, impact-resistant, closable, and stable.
The base is made from a high-strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line.
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K Number
K190240Device Name
Tiger Sharps Containers
Manufacturer
International Marketing Specialists Inc.
Date Cleared
2019-05-31
(114 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
International Marketing Specialists Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tiger Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.
All device models only be used with appropriate mounting accessories.
Device Description
Tiger Sharps Containers constructed of injection molded polypropylene plastic. They are designed for a single-use (disposable) by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable.
Lids and closures are uncolored translucent material allowing for a visual determination of fill level. The base is made from a high strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the level line on the product identification label.
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