AccessGUDID - DEVICE: Amico Diagnostic Station (00697077001292)

GUDID

Device Identifier (DI) Information

Brand Name: Amico Diagnostic Station
Version or Model: DS-UDM-CHFL-DXX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Amico Diagnostic Incorporated

Primary DI Number: 00697077001292
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203163290 *Terms of Use

Device Description: Diagnostic Station Wall Mount, Ophthal Halogen & Oto LED, Spec Dispenser Coaxial Ophthalmoscope Instrument Head, 3.5V Halogen (DI 00697077000028)

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:	No
Prescription Use (Rx):	Yes
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?
46786	Direct ophthalmoscope	An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLI	Ophthalmoscope, Ac-Powered
ERA	Otoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 1c49fc35-9eae-4f4e-b7b9-89eda1431b7d
Public Version Date: March 05, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016