AccessGUDID - DEVICE: 10732 Dual Tip Skin Marker; Regular/Fine Tip Gentian Violet; w/Ruler and Labels (00787551008524)

GUDID

Device Identifier (DI) Information

Brand Name: 10732 Dual Tip Skin Marker; Regular/Fine Tip Gentian Violet; w/Ruler and Labels
Version or Model: 10732
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10732
Company Name: XODUS MEDICAL, INC.

Primary DI Number: 00787551008524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868042664 *Terms of Use

Device Description: 10732 Dual Tip Skin Marker; Regular and Fine Tip Gentian Violet; w/ Ruler and Labels

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:	Yes
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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: c2f9bb74-d517-4306-81c0-21e3c81a5cf6
Public Version Date: October 17, 2023
Public Version Number: 2
DI Record Publish Date: December 13, 2022