AccessGUDID - DEVICE: StarchMark® Breast Tissue Marker (00801741032189)

GUDID

Device Identifier (DI) Information

Brand Name: StarchMark® Breast Tissue Marker
Version or Model: STMKMT11GSS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: STMKMT11GSS
Company Name: SENORX, INC.

Primary DI Number: 00801741032189
Issuing Agency: GS1
Commercial Distribution End Date: October 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 043674543 *Terms of Use

Device Description: STARCHMARK® Breast Tissue Marker, 11 Ga Mammotome, 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
NEU	MARKER, RADIOGRAPHIC, IMPLANTABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131654	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 11 Gauge

Device Record Status

Public Device Record Key: a2758072-cda4-44b1-ad53-5b077b4a6b2b
Public Version Date: April 17, 2024
Public Version Number: 6
DI Record Publish Date: October 02, 2015