AccessGUDID - DEVICE: FUSION-DOE Light System (00860179001075)

GUDID

Device Identifier (DI) Information

Brand Name: FUSION-DOE Light System
Version or Model: 7700512
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7700512
Company Name: Dentlight Inc.

Primary DI Number: 00860179001075
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 171208585 *Terms of Use

Device Description: FUSION-DOE Light System

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:	Yes
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?
60827	Oral lesion examination light	A battery-powered, hand-held, torch-like device designed to visualize, and facilitate identification of, abnormalities of the oral mucosa (e.g., malignancy, dysplasia, bacterial and fungal infections) using one or more wavelengths (colours) of light. It may be supplied with disposable accessories (e.g., mirrors, tinted spectacles, lens covers). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXV	Diagnostic Light, Soft Tissue Detector

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101140	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
Storage Environment Temperature: between -10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c0f4946a-576c-4e2e-a867-6b1c2935c6e2
Public Version Date: January 25, 2022
Public Version Number: 2
DI Record Publish Date: August 09, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8007636901
Email: sales1@dentlight.com

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