SyntrFuge System

Primary DI
00860005496709
Brand
SyntrFuge System
Company
Syntr Health Technologies, Inc
Model
90-1001
Catalog number
90-1001
Device description
Fat microsizing unit.
Published
2024-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QKLLipoaspirate Washing System For Aesthetic Body Contouring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKLLipoaspirate Washing System For Aesthetic Body ContouringGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005496709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005496709008600054967098600054967090860005496709

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
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080331095
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005496723SyntrFuge System 3090-100390-10032024-10-17
00860005496730AdipoSizer System90-100690-10062024-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260170881076FillerCollectorHuman Med AGQKL2025-07-30
04260170881366FillerCollectorHuman Med AGQKL2025-07-30
14260170881370Disposable Set FillerCollectorHuman Med AGQKL2025-07-30
04260170881380LipoCollector 3, completeHuman Med AGQKL2025-07-30
14260170881400Disposable Set LipoCollector IIIHuman Med AGQKL2025-07-30
14260170881417Drainage Set LipoCollector III PlusHuman Med AGQKL2025-07-30
14260170881424Extraction cannula, LCHuman Med AGQKL2025-07-30
14260170881431Extraction cannulaHuman Med AGQKL2025-07-30
14260170881448Extraction cannulaHuman Med AGQKL2025-07-30
14260170881509Extraction tubeHuman Med AGQKL2025-07-30
14260170881578FillerCollector, Stand, SU, SetHuman Med AGQKL2025-07-30
00860005496723SyntrFuge System 30Syntr Health Technologies, IncQKL2024-10-17
00850034511009Puregraft 850 System Twin PackBimini Technologies LLCQKL2024-08-22
07290110123055CellfieALMA LASERS LTD.QKL2023-09-21
08800080200015Smart kit BasicBSLQKL2023-05-11
08800080200022Smart kit BasicBSLQKL2023-05-11
08800080200039Smart kit BasicBSLQKL2023-05-11
08800080200046Smart kit BasicBSLQKL2023-05-11
08800080200053Smart kit BasicBSLQKL2023-05-11
08800080200060Smart kit BasicBSLQKL2023-05-11
08800080201012Smart kit ProBSLQKL2023-05-11
08800080201029Smart kit ProBSLQKL2023-05-11
08800080201036Smart kit ProBSLQKL2023-05-11
08800080201043Smart kit ProBSLQKL2023-05-11
08800080201050Smart kit ProBSLQKL2023-05-11
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08800080202019AdinizerBSLQKL2023-05-11
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08800080202040AdinizerBSLQKL2023-05-11