AccessGUDID - DEVICE: OtoSight Speculum Tip Combination Package (00850013784110)

GUDID

Device Identifier (DI) Information

Brand Name: OtoSight Speculum Tip Combination Package
Version or Model: Combo
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Photonicare, Inc.

Primary DI Number: 00850013784110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078873691 *Terms of Use

Device Description: Combination Package for shipping containing QTY 100 Large OtoSight Speculum Tips (Unit of Use DI #00850013784073) packaged in 5 20-packs (DI#10850013784070) and QTY 100 Standard OtoSight Speculum Tips (Unit of Use DI #00850013784080) packaged in 5 20-packs (DI#10850013784087).

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:	Yes
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?
34897	Ear speculum, single-use	A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use 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: d178ba4e-a2a6-40ef-8d6d-73ed98bda8b0
Public Version Date: April 25, 2022
Public Version Number: 1
DI Record Publish Date: April 15, 2022