Asp Plastics Pty , Ltd.
US Last updated 23 May 2026
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- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Fitpack Ref K060037
FDA establishments
- Asp Plastics Pty Ltd. ST-MARYS New South Wales · AU FEI 3003756985
What Asp Plastics Pty , Ltd. makes
Asp Plastics Pty, Ltd. manufactures medical packaging solutions, including the FITPACK system designed for sterile barrier protection of medical devices and instruments.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. The manufacturer operates from the United States.
Frequently asked questions
What types of medical devices does Asp Plastics Pty, Ltd. manufacture?
Asp Plastics Pty, Ltd. specializes in medical packaging solutions, specifically the FITPACK system. This system is designed to provide sterile barrier protection for medical devices and instruments, ensuring they remain uncontaminated during storage and transport.
Where is Asp Plastics Pty, Ltd. based?
Asp Plastics Pty, Ltd. operates from the United States. The company’s headquarters and manufacturing facilities are located there, supporting its global distribution of medical packaging solutions.
Which regulatory registries or databases list Asp Plastics Pty, Ltd.’s devices?
Asp Plastics Pty, Ltd.’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II medical devices, which require premarket notification to demonstrate substantial equivalence to a legally marketed predicate device.
How are Asp Plastics Pty, Ltd.’s devices classified under FDA regulations?
Asp Plastics Pty, Ltd.’s devices fall under FDA Class II classification. This classification applies to products that pose moderate risk and require special controls—such as packaging systems—to ensure safety and effectiveness before being authorised.
Information
- Country
- US