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
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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 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