DEVICE: OralID (00370275123163)

Device Identifier (DI) Information

OralID
FS-11
In Commercial Distribution

Forward Science Technologies LLC
00370275123163
GS1

1
079212068 *Terms of Use
OralID is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
NXV Diagnostic Light, Soft Tissue Detector
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K123169 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0632d2a9-8e31-46a7-9f2b-ca42f1e165f9
July 06, 2018
3
October 03, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
855-696-7254
info@forwardscience.com
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