FDA.reportPublic FDA data

SmartGraft™ 30 System

Primary DI
00852059007048
Brand
SmartGraft™ 30 System
Company
INGENERON, INC.
Model
10840-01
Catalog number
10840-01
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUUSystem, Suction, Lipoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852059007048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852059007048008520590070488520590070480852059007048

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue collection/washing setA collection of sterile devices designed as a closed system for the harvesting and rapid treatment of autologous fat tissue for reinjection back into the patient from which it was taken for aesthetic body contouring. It typically consists of various chambers (e.g., a collection bag, waste material bag, and a cleaned tissue bag), flexible tubing, an intravenous (IV) spike for connection to the washing solutions, and a contiguous filter mesh which dialyses the fat graft. It is used in conjunction with appropriate IV solutions within the sterile field of intervention for plastic and reconstructive surgery and cosmetic surgery. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
138619205
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852059007055SmartGraft™ 200 System10860-0110860-012016-09-23
00852059007109Tissue Processing Unit10715-0110715-012018-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130455843Medco ManufacturingMedco Manufacturing LLCMUU2026-03-31
04260632793640TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
04260632794043TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00810130455812Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455829Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455485Medco ManufacturingMedco Manufacturing LLCMUU2025-09-11
00810130455195Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
00810130455201Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
08800052308909FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052308886FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052316904FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
00810130454839Medco ManufacturingMedco Manufacturing LLCMUU2025-02-27
00385640084987SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640084994SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085007SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085014SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085021SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31
07612367003902Tubing holder right sideMedela AGMUU2024-05-31