AccessGUDID - DEVICE: LED Powerslot (D798LEDPS0)

GUDID

Device Identifier (DI) Information

Brand Name: LED Powerslot
Version or Model: LEDPS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LEDPS
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798LEDPS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: LED Powerslot is for use with the NM390 and NM468 curing light by Reliance

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?
48101	Dental photo-activated disinfection system handpiece light guide	A detachable component of a dental photo-activated disinfection system that is attached to the distal end of the system's handpiece and designed to guide and transmit the photo-activating light from the handpiece into the hard and soft tissue within the oral cavity as part of the bacteria-eliminating process. The device is typically a rigid, curved tube containing a fibreoptic core and is sterilized between patients. It can be used without the attachment of a dedicated tip when larger tissue areas are to be treated. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAY	Light, Fiber Optic, Dental

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: e1876795-c033-47be-92dd-72a3c35fb292
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 20, 2016

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 6307734009
Email: paulgropi@aol.com

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