AccessGUDID - DEVICE: Image Tooth Shade Acrylic (00304040001042)

GUDID

Device Identifier (DI) Information

Brand Name: Image Tooth Shade Acrylic
Version or Model: 2282568
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2282568
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040001042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Image Tooth Shade Acrylic

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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Storage this product at room temperature, in a cool area.
Storage Environment Temperature: between 2 and 23 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Plastic jar x 4 oz
Weight: 125 Gram

Device Record Status

Public Device Record Key: ff4ed759-14ad-4e72-ad33-958789352d41
Public Version Date: October 29, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016