KryoSure® Overwraps

KryoSure® Overwraps

Name

KryoSure®  Overwrap OP-0020-NS

KryoSure® Overwrap OP-0061-NS

KryoSure® Overwrap OP-0120-NS

KryoSure® Overwrap OP-0300

Order Number

3404 3416 3407 3412

Inside Dimension

10.2 x 20.8 cm 14.2 x 22.9 cm 13.5 x 24.4 cm 13.7 x 27.9 cm

Sterility

non-sterile non-sterile non-sterile sterile

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • cGMP declaration and cGMP and compliance to 21CFR8201 on each Certificates of Conformance
  • Separate Certificate of Sterilization for each lot (for sterile Overwraps only)
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs.

 

Please contact our Regulatory Support Team for all your regulatory requests & questions:

Phone:     +49 761 88 88 9 – 0
Email:       regulatorysupport@cellgenix.com    


121CFR820: Quality System Regulations for Medical Devices of the Code of Federal Regulations of the United States

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