AccessGUDID - DEVICE: Safco Fluora Trays (D72310273223)

GUDID

Device Identifier (DI) Information

Brand Name: Safco Fluora Trays
Version or Model: 1027322
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1027322
Company Name: SAFCO DENTAL SUPPLY CO.

Primary DI Number: D72310273223
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 020417380 *Terms of Use

Device Description: Safco Fluora trays small yellow 100/b

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:	Yes
Prescription Use (Rx):	No
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?
63350	Teeth whitening tray	A custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMT	TRAY, FLUORIDE, DISPOSABLE

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: ef06776f-bd48-467d-b988-618b2ac09595
Public Version Date: November 29, 2022
Public Version Number: 1
DI Record Publish Date: November 21, 2022