Product Description

Medical TPU thermoplastic polyurethane elastomer (TPU)for a demanding X-ray detectable thread market,

Aromatic polyether TPU radiopaque grades (20% loading of barium sulfate) have very good mechanical properties, chemical resistance, radiopacity, and can be color-matched.

Aromatic polyether TPU radiopaque grades (40% loading of barium sulfate) are medical grade aromatic TPUs with good mechanical properties, very good chemical resistance, radiopacity, and can be color-matched.

Descriptions:

Medical TPU Loading of Barium Sulfate for X-ray Detectable Thread

Medical Customer Questionnaire :

1),Customer Background Information
Original Equipment Manufacturer company name?
Converter / Molder / Processor company name?

2)Medical Polymer Overview
What is the approximate yearly commercial demand?

3),Medical Drug / Device Overview(Please be as descriptive as possible without disclosing confidential information in answering the following questions in order to speed our response.)
Please describe the final medical device / drug delivery device application and use in detail.
Please describe how the material is used in the device.  Include where in the device the material is used, how it will be used, and what function it is performing.
Please provide a diagram or picture to illustrate the use of the material.
Does administration of this application involve supervision of a healthcare professional?
Will the application be single use (disposable) or repeated use?
Is this request for a new application?  (Yes/No)?If No, is it for an existing application?

4),Medical Polymer Product Usage
In what form will the material be used (molded part, tubing, film, fiber, etc.)?
How will the material be processed/manufactured (extrusion, injection moulding, etc.)?
What sterilization technique is used (if any)?
The human body?  (Yes/No)If 'Yes' then please provide a description of the part(s) of the body where the contact occurs, and the duration of contact.
Liquids or fluids entering the human body? (Yes/No)If 'Yes' then please provide a detailed description of the types of liquids, their function and duration of contact with these liquids Blood? (Yes/No)If 'Yes' then please provide a description of whether the blood contact is inside or outside the body, and the duration of the contact.
Is the device to be used for delivery of a "drug" with "drug" to include but not limited to antibiotic, antimicrobial, hormone or active pharmaceutical ingredient.

5),Regulatory
Is the medical device / drug delivery device classified by the FDA? If yes, what is the class of the device?
510K Exempt  (Yes/No)?If no, will human clinical be performed? (Yes/No)?
What certifications are required by the customer (USP, ISO 10993, EU Pharm, etc.)?
Is a letter of access to a FDA masterfile required for the application?
Is the medical device / drug delivery device classified by any regulatory authorities other than the FDA, e.g. in the EU?If yes, please provide details
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** Notice :

CNDOMED™-Registered service trade name in HK & China for biocompatibility polymers in medical & healthcare industry application.