AccessGUDID - DEVICE: Key Surgical Skin Markers (00849771030485)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Skin Markers
Version or Model: SM-300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SM300
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771030485
Issuing Agency: GS1
Commercial Distribution End Date: February 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Skin Markers, Sterile, Dual tip (1 mm and 0.5 mm) with Ruler and 6 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":	No
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: 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: d11f55e4-c124-4f8c-885f-f4c77e3687c1
Public Version Date: February 13, 2024
Public Version Number: 4
DI Record Publish Date: December 09, 2020