DEVICE: NuFACE (00856349005639)

Download: XML | JSON

Device Identifier (DI) Information

NuFACE
40280

Nuface
00856349005639
GS1
1
Refreshed TWR Attachment
CLOSE

Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Red-light phototherapy unit, battery-powered A battery-powered device designed to emit a low-level narrow-band (LLNB) red light in the visible wavelength around 630 nm, with the intent to modify cellular metabolism and/or improve blood flow through increased vasodilation primarily for the accelerated healing of cutaneous or mucosal wounds. This is a hand-held device that may be operated by the patient/user and is suitable for home-use. It may be used to help treat intraoral, nasal, or dermal conditions such as oral ulcers, gingival inflammation, bad breath, allergic rhinitis (hay fever), or nasal congestion.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
No Product Codes
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 22, 2016

CLOSE

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
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE