AccessGUDID - DEVICE: Medical Action Industries (20809160022143)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Action Industries
Version or Model: NS215
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDICAL ACTION INDUSTRIES INC.

Primary DI Number: 20809160022143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 092364462 *Terms of Use

Device Description: Pen: Marking FP Ns 500/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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
61576	Skin marking pen, single-use, non-sterile	A non-sterile, dedicated pen (typically a felt-tip pen) intended to be used to delineate areas on the skin surface of a patient (e.g., for dermatology applications) utilizing non-toxic ink. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HRP	PEN, MARKING, SURGICAL

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
Special Storage Condition, Specify:
Special Storage Condition, Specify: store at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6d3fcb5b-1339-4074-83d6-578f0e5dab77
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 20, 2016