FDA.reportPublic FDA data

Tissue Processing Unit

Primary DI
00852059007109
Brand
Tissue Processing Unit
Company
INGENERON, INC.
Model
10715-01
Catalog number
10715-01
Published
2018-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852059007109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852059007109008520590071098520590071090852059007109

GMDN Terms#

Term, Definition table
TermDefinition
Adipose tissue stem cell recovery unitA portable mains electricity (AC-powered) device designed to obtain stem and regenerative cells from the adipose tissue of a patient immediately following harvesting of the tissue. 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 cells are typically used in surgical (e.g., general, plastic and reconstructive, orthopaedic) or disease treatment (e.g., cardiovascular) applications.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442035148210techsupport@ingeneron.com
+17134409900sales@ingeneron.com

Regulatory Flags#

DUNS number
138619205
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852059007048SmartGraft™ 30 System10840-0110840-012016-09-23
00852059007055SmartGraft™ 200 System10860-0110860-012016-09-23

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