O-Wrap

GUDID 10816203022575

O-Wrap, overwrap pouch for freezing, 4X19cm

ORIGEN BIOMEDICAL, INC.

Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container

• Primary Device ID: 10816203022575
• NIH Device Record Key: 19f29bf3-ffb5-4006-a389-d1c00015de5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Wrap
• Version Model Number: OW0419
• Company DUNS: 625272232
• Company Name: ORIGEN BIOMEDICAL, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816203022578 [Unit of Use]
GS1	10816203022575 [Primary]

FDA Product Code

• KJG: Tube, Tissue Culture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-03-27

On-Brand Devices [O-Wrap]

• 10816203022575: O-Wrap, overwrap pouch for freezing, 4X19cm
• 00816203022615: O-Wrap, overwrap pouch for freezing,19x36cm
• 00816203022608: O-Wrap, overwrap pouch for freezing, 14x30cm
• 00816203022592: O-Wrap, overwrap pouch for freezing, 9x18cm
• 00816203022585: O-Wrap, overwrap pouch for freezing, 9x9cm.
• 00816203022257: O-Wrap, overwrap pouch for freezing, 24x36cm
• 00816203022226: O-Wrap, overwrap pouch for freezing,19x50cm
• 00816203022202: O-Wrap overwrap 3-layer pouch for freezing, 14x30cm