AccessGUDID - DEVICE: Gel Mark Ultra™ Breast Tissue Marker (00801741031854)

GUDID

Device Identifier (DI) Information

Brand Name: Gel Mark Ultra™ Breast Tissue Marker
Version or Model: GMUEC10GSS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GMUEC10GSS
Company Name: SENORX, INC.

Primary DI Number: 00801741031854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043674543 *Terms of Use

Device Description: GEL MARK ULTRA™ Breast Tissue Marker, 10 Ga EnCor, SS "Omega"

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
FZP	CLIP, IMPLANTABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011402	000

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
Handling Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 10 Gauge

Device Record Status

Public Device Record Key: 5d0dfaf6-8c1e-402e-a753-2b656f2f7d90
Public Version Date: September 18, 2023
Public Version Number: 5
DI Record Publish Date: October 01, 2015