AccessGUDID - DEVICE: Q-Optics Loupe and Light Combo Case (00814005024332)

GUDID

Device Identifier (DI) Information

Brand Name: Q-Optics Loupe and Light Combo Case
Version or Model: Q-Optics Loupe and Light Combo Case
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 308-10028
Company Name: Quality Aspirators, Inc.

Primary DI Number: 00814005024332
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121431159 *Terms of Use

Device Description: Q-Optics Loupe and Light Combo Case

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
32692	Surgical binoculars, reusable	A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJH	Loupe, binocular, low power

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: 8a5fb51e-d71f-487a-9af5-eb0351844244
Public Version Date: March 07, 2025
Public Version Number: 1
DI Record Publish Date: February 27, 2025