AccessGUDID - DEVICE: Alleset (16931918124735)

GUDID

Device Identifier (DI) Information

Brand Name: Alleset
Version or Model: Model 25-SX003-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRI Medical & Electronic Technology Co., Ltd.

Primary DI Number: 16931918124735
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 679894738 *Terms of Use

Device Description: Skin Marker_Standard Tip with Ruler and Lables_ XL Prep-Resistant Ink_Sterile_100EA/CS

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: Yes

Sterilization Method [?]
Ethylene Oxide

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: bb1e82fc-0161-4949-8b71-56a8793a8e95
Public Version Date: February 12, 2021
Public Version Number: 1
DI Record Publish Date: February 04, 2021