AccessGUDID - DEVICE: API 2 LED Wireless Slimline Student Kit (05055272712613)

GUDID

Device Identifier (DI) Information

Brand Name: API 2 LED Wireless Slimline Student Kit
Version or Model: 1205-P-2003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KEELER LIMITED

Primary DI Number: 05055272712613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 210164398 *Terms of Use

Device Description: No description.

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):	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?
46792	Indirect binocular ophthalmoscope, line-powered	A mains electricity (AC-powered), ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. It typically consists of a main light to illuminate the interior of the eyeball, a system of lenses and filters and an illuminator beam to eliminate reflexes. Also called a binocular indirect ophthalmoscope (BIO), it produces images that better overcome large refractive errors and subtle colour differences. It can be mounted on a headband or spectacle frames and the power is run through a transformer to reduce this to low-voltage.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HLI	Ophthalmoscope, Ac-Powered

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: 0e215f3f-ec9b-4495-bd27-fff06c275961
Public Version Date: February 06, 2023
Public Version Number: 4
DI Record Publish Date: August 16, 2016