AccessGUDID - DEVICE: MediChoice (30885632120170)

GUDID

Device Identifier (DI) Information

Brand Name: MediChoice
Version or Model: MKR2250
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 30885632120170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Marker Skin Correct Site With Sleeve Mini Gentian Violet Non-Sterile Single-Patient Use Not Made With Natural Rubber Latex MediChoice

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: 09ac8016-f3ab-4cc4-9ec3-5dc1909a1fed
Public Version Date: October 14, 2020
Public Version Number: 1
DI Record Publish Date: October 06, 2020