AccessGUDID - DEVICE: NS10402 Correct Site Marker(small); Gentian Violet Ink; In Dispenser Box(50/box) (00787551008623)

GUDID

Device Identifier (DI) Information

Brand Name: NS10402 Correct Site Marker(small); Gentian Violet Ink; In Dispenser Box(50/box)
Version or Model: NS10402
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NS10402
Company Name: XODUS MEDICAL, INC.

Primary DI Number: 00787551008623
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868042664 *Terms of Use

Device Description: NS10402 Correct Site Marker (small); Gentian Violet Ink; In Dispenser Box (50/box)

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):	No
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?
61575	Skin marking pen, single-use	A dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZZ	MARKER, SKIN

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 4aac352c-daab-4944-be33-bee6af1a0a38
Public Version Date: October 17, 2023
Public Version Number: 2
DI Record Publish Date: December 13, 2022