Home GUDID 00860005496730 AdipoSizer System
Primary DI 00860005496730
Brand AdipoSizer System
Company Syntr Health Technologies, Inc
Model 90-1006
Catalog number 90-1006
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 Code Name KDC Instrument, Surgical, Disposable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KDC Instrument, Surgical, Disposable General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860005496730 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860005496730 00860005496730 860005496730 0860005496730
GMDN Terms# Term, Definition table Term Definition Autologous adipose tissue collection/washing set A 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 Type Low High Condition Storage Environment Temperature 18 Degrees Celsius 28 Degrees Celsius
Regulatory Flags# DUNS number 080331095 Device count 1 DM exempt false Premarket exempt true 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 DI Brand Model Catalog Published 00860005496709 SyntrFuge System 90-1001 90-1001 2024-10-17 00860005496723 SyntrFuge System 30 90-1003 90-1003 2024-10-17
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