KryoSure® Overwraps

KryoSure Overwraps – protect your valuable biologics

KryoSure Overwraps provide an added layer of protection during cryopreservation. They are made from the same USP Class VI, fluorinated ethylene propylene (FEP) used for KryoSure Cryopreservation Bags. Most overwraps are available as both sterile and non-sterile products.

Due to the FEP material characteristics KryoSure Overwraps remain transparent and flexible at temperatures as low as -200°C.

 

Order Information
Inquiries

 

 

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

3404341634073412

Inside Dimension

10.2 x 20.8 cm14.2 x 22.9 cm13.5 x 24.4 cm13.7 x 27.9 cm

Sterility

non-sterilenon-sterilenon-sterilesterile

Regulatory Support

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

  • cGMP declaration and cGMP and compliance to 21CFR8201 on Data Sheets and 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 – 302
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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