AccessGUDID - DEVICE: OtoSight Middle Ear Scope (00850013784004)

GUDID

Device Identifier (DI) Information

Brand Name: OtoSight Middle Ear Scope
Version or Model: 34R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Photonicare, Inc.

Primary DI Number: 00850013784004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078873691 *Terms of Use

Device Description: The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults. It is available with and without a battery.

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

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44929	Otoscope, endoscopic	An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJG	Device System, Imaging, Tympanic Membrane And Middle Ear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191804	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: 6393b361-3a2a-445b-8002-56cf8f8d84b3
Public Version Date: March 31, 2025
Public Version Number: 4
DI Record Publish Date: April 15, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00850013784035	1	00850013784004	In Commercial Distribution	Shipping Box
00850013784141	1	00850013784004	In Commercial Distribution	Box with WA Adapter
00850013784172	1	00850013784004	In Commercial Distribution	Box