Home GUDID 00864661000133 TraceIT Tissue Marker 3mL 1-UP
Primary DI 00864661000133
Brand TraceIT Tissue Marker 3mL 1-UP
Company AUGMENIX, INC.
Model TH-1031
Catalog number TH-1031
Device description TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, radiopaque cross-linked PEG hydrogel with an endcap.
Published 2015-12-10
Public version status Update
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 NEU Marker, Radiographic, Implantable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NEU Marker, Radiographic, Implantable General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00864661000133 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 00864661000133 00864661000133 864661000133 0864661000133
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 960905862 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 false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00864661000119 TraceIT Tissue Marker 1-UP TH-1011 TH-1011 2015-12-10 10864661000116 TraceIT Tissue Marker 5-UP TH-1015 TH-1015 2015-12-11 10864661000130 TraceIT Tissue Marker 3mL 5-UP TH-1035 TH-1035 2015-12-11
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