Tissue Processing Unit 10715-01

GUDID 00852059007109

INGENERON, INC.

Adipose tissue stem cell recovery unit Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality Stromal vascular fraction recovery unit, multi-modality

• Primary Device ID: 00852059007109
• NIH Device Record Key: ab411e54-fa5e-4fb1-ac3b-6d83da742636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue Processing Unit
• Version Model Number: 10715-01
• Catalog Number: 10715-01
• Company DUNS: 138619205
• Company Name: INGENERON, INC.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com
• Phone: +442035148210
• Email: techsupport@ingeneron.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852059007109 [Primary]

FDA Product Code

• JQC: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-05
• Device Publish Date: 2018-10-05

Devices Manufactured by INGENERON, INC.

• 00852059007048 - SmartGraft™ 30 System: 2018-12-03
• 00852059007055 - SmartGraft™ 200 System: 2018-12-03
• 00852059007109 - Tissue Processing Unit: 2018-11-05
• 00852059007109 - Tissue Processing Unit: 2018-11-05