AccessGUDID - DEVICE: Novocol GRANITEC BLUE BAND CEMENT LIGHT CURE KIT (07540187001085)

GUDID

Device Identifier (DI) Information

Brand Name: Novocol GRANITEC BLUE BAND CEMENT LIGHT CURE KIT
Version or Model: FP-NOVOINC-056
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEPTODONT, INC

Primary DI Number: 07540187001085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012925513 *Terms of Use

Device Description: Novocol GRANITEC BLUE BAND CEMENT LIGHT CURE KIT- 6/pk

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:	Yes
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?
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	Cement, Dental

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ab2f43e-630f-4f2c-b230-26862ca7855b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 25, 2017