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USP Class VI Adhesives
USP Class VI Approved Adhesives for Medical Device Applications
Master Bond’s biocompatible adhesives are designed to meet the needs of medical device manufacturers. Compounds withstand various types of sterilization methods.

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Momentive Performance Materials TUFEL™ II 94205 Low Volatile Extrusion Heat Cured Rubber
Categories: Polymer; Thermoset; Rubber or Thermoset Elastomer (TSE); Silicone; Silicone Rubber

Material Notes: Heat cured rubber is a high consistency product that can be molded, extruded or calendered using conventional rubber processing equipment to meet a wide range of cost, durability and performance standards.

TUFEL II Low Volatile 94205 is a member of the Addition Curing Portfolio. It is a platinum (addition/heat) curable, one-part compound. This product has been optimized for molding processes and is intended for application in the Healthcare industry.

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Physical PropertiesOriginal ValueComments
Specific Gravity 1.07 g/cc
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore A 22
Tensile Strength 8.20 MPa
Elongation at Break 1000 %
Tear Strength 22.0 kN/mDie B
 
Optical PropertiesOriginal ValueComments
Transmission, Visible 20 %translucent; thickness unknown
 
Compliance PropertiesOriginal ValueComments
FDA YesFDA Indirect food contact - Rubber articles intended for repeated use - FDA Reg 21CFR177.2600
USP Class VI YesUSP Class VI methods: Intramuscular implantation, intracutaneous injection, & systematic injection
 
Descriptive Properties
AppearanceTranslucent
BfRproduct is compositionally compliantRecommendation XV Silicones; post cured (4h/200°C)

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PGE8V821 / 109081

USP Class VI Adhesives
USP Class VI Approved Adhesives for Medical Device Applications
Master Bond’s biocompatible adhesives are designed to meet the needs of medical device manufacturers. Compounds withstand various types of sterilization methods.

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