SmartGraft™ 30 System 10840-01

GUDID 00852059007048

INGENERON, INC.

Autologous adipose tissue collection/washing set

• Primary Device ID: 00852059007048
• NIH Device Record Key: cd709a28-f969-4c54-8036-49e8c284ff21
• Commercial Distribution Discontinuation: 2018-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SmartGraft™ 30 System
• Version Model Number: 10840-01
• Catalog Number: 10840-01
• Company DUNS: 138619205
• Company Name: INGENERON, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: +442035148210
• Email: techsupport@ingeneron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852059007048 [Primary]

FDA Product Code

• MUU: System, Suction, Lipoplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-03
• Device Publish Date: 2016-09-23

Devices Manufactured by INGENERON, INC.

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