AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094170726)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901023
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 12234-D
Company Name: WELCH ALLYN, INC.

Primary DI Number: 00732094170726
Issuing Agency: GS1
Commercial Distribution End Date: November 19, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: Welch Allyn Binocular Indirect Ophthalmoscope with Padded Headband, Colbalt-Blue Filter, Diffuser Filter, Power Cord (8 ft/2.7 m), Small Carrying Case; Portable Power Source (#s 7436X); IEC Plug Type-G

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?
46790	Indirect binocular ophthalmoscope	An electrically-powered, head-worn, ophthalmic instrument designed to be held arm’s length from the patient to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, vitreous] using the examiner’s two eyes simultaneously (stereoscopic vision). It is intended to provide a wide field of view and produce an inverted (reversed) image of approximately 2 to 5 times magnification. It typically consists of a main light to illuminate the interior of the eyeball, lenses, filters and an illuminator beam to eliminate reflexes; it can be mounted on a headband or spectacle frames.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLI	Ophthalmoscope, ac-powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930023	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: 2d94283b-6f8f-413b-8441-d1e192c5dbe6
Public Version Date: November 22, 2021
Public Version Number: 2
DI Record Publish Date: May 06, 2021