AccessGUDID - DEVICE: Scanlan® PrepMARK (00846159025408)

GUDID

Device Identifier (DI) Information

Brand Name: Scanlan® PrepMARK
Version or Model: 1001-730
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1001-730
Company Name: SCANLAN INTERNATIONAL INC

Primary DI Number: 00846159025408
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023055619 *Terms of Use

Device Description: PrepMARK Surgical Skin Marker, Gentian Violet, Regular Tip (1per ster pkg)

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":	No
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?
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: 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: bbc9a4a0-5a5d-46d4-932b-6bc37f7ad8e7
Public Version Date: September 10, 2019
Public Version Number: 2
DI Record Publish Date: July 16, 2019