AccessGUDID - DEVICE: RHA (00627843652021)

GUDID

Device Identifier (DI) Information

Brand Name: RHA
Version or Model: RHA2020/2020-U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Annidis Health Systems Corp

Primary DI Number: 00627843652021
Issuing Agency: GS1
Commercial Distribution End Date: August 05, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 243651440 *Terms of Use

Device Description: The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
46787	Direct ophthalmoscope, line-powered	A mains electricity (AC-powered), hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of, a built-in light that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single hole through which the examiner will view, and a dial containing several lenses of different powers that can be alternated by the examiner whilst viewing. It produces an upright, or unreversed, image of approximately 15 times magnification. The power is run through a transformer to reduce this to low-voltage.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HKI	Camera, Ophthalmic, Ac-Powered
HLI	Ophthalmoscope, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111531	000

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: 27e6a7c9-f70d-4462-ac44-af63b1c40370
Public Version Date: August 05, 2021
Public Version Number: 4
DI Record Publish Date: August 05, 2016