AccessGUDID - DEVICE: TraceIT Tissue Marker 1-UP (00864661000119)

GUDID

Device Identifier (DI) Information

Brand Name: TraceIT Tissue Marker 1-UP
Version or Model: TH-1011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TH-1011
Company Name: AUGMENIX, INC.

Primary DI Number: 00864661000119
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960905862 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40808	Radiological image marker, implantable	A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NEU	Marker, Radiographic, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 60 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f044b484-57ec-4eae-8451-277f6fa6508c
Public Version Date: September 18, 2023
Public Version Number: 7
DI Record Publish Date: December 10, 2015