AccessGUDID - DEVICE: Osstem Implant Co.,Ltd. (08800000995649)

GUDID

Device Identifier (DI) Information

Brand Name: Osstem Implant Co.,Ltd.
Version or Model: SNAP Wireless
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Osstem Implant Co.,Ltd.

Primary DI Number: 08800000995649
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694893867 *Terms of Use

Device Description: This device is an oral camera device that can be magnified in the light of the inside of the mouth, and is used by dentists to photograph the inside of the mouth during oral examination. It consists of a camera head, a battery, a charging cradle, and a receiver module. Investigate the light from the mouth LED to capture the image from the camera module and wirelessly transmit the data via UWB. Additionally, the transmitted image can be viewed using a separate viewer program on the PC ti which the receiver module is connected.

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?
63672	Intraoral camera	An electro-optical device designed for image and/or video capture of the teeth and other intraoral anatomy, to assist with the diagnosis/management of dental/intraoral conditions (e.g., caries, plaque, calculus). It may be provided with specialized camera heads for specific types of examination (e.g., acquiring high resolution pictures/videos, emitting violet or infrared light), as well as camera holders and cables; it connects to an off-the-shelf computer (not included) for the power/processing/display.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJK	Intraoral Camera

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 7b3daecc-8d12-4777-b04f-306f983b5ebc
Public Version Date: December 08, 2022
Public Version Number: 1
DI Record Publish Date: November 30, 2022