AccessGUDID - DEVICE: NeoGlo® (00812594012655)

GUDID

Device Identifier (DI) Information

Brand Name: NeoGlo®
Version or Model: White
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N555WH
Company Name: Neotech Products LLC

Primary DI Number: 00812594012655
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198013435 *Terms of Use

Device Description: The NeoGlo Transilluminator is a hand-held, battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.

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:	No
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?
36761	Visible-light skin transilluminator	An electrically-powered device intended to use visible light (e.g., red LED light) to illuminate the skin and subcutaneous soft tissues, rendering them translucent for examination. It is typically used to help locate peripheral veins beneath the skin to assist a healthcare professional during venipuncture or sclerotherapy, or for examining subcutaneous and scrotal tissue/contents for lesions or anatomical abnormalities. It is typically a portable hand-held device which may also be known as a vein finder/viewer, diaphanoscope, phaneroscope, or light scanner.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJN	Transilluminator, Battery-Powered

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: 3c335e70-38b5-41eb-a6df-cb7a1cb76e3e
Public Version Date: September 20, 2023
Public Version Number: 7
DI Record Publish Date: September 05, 2017