Tissue Processing Unit

Basic Information

• Brand Name: Tissue Processing Unit
• Primary DI: 00852059007109
• Version / Model: 10715-01
• Catalog Number: 10715-01
• Company Name: INGENERON, INC.
• Labeler DUNS: 138619205
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-05
• Public Version: 2
• Public Version Date: 2021-10-19
• Public Version Status: Update
• Public Device Record Key: ab411e54-fa5e-4fb1-ac3b-6d83da742636

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47500	Stromal vascular fraction recovery unit, multi-modality	A portable mains electricity (AC-powered) device designed to obtain a stromal vascular fraction (SVF) [stem and regenerative cells from the adipose tissue of a patient] using multiple procedural modalities immediately following tissue harvesting. It is a programmable device consisting of a centrifuge, pumping mechanisms, valves, agitator mechanism, and/or vacuum pump that functions in combination with a proteolytic enzyme and a disposable set to digest adipose tissue and subsequently wash and concentrate its stem and regenerative cells. The SVF is typically used in surgical (e.g., general, plastic and reconstructive, orthopaedic) or disease treatment (e.g., cardiovascular) applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852059007109	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]