AccessGUDID - DEVICE: GC Tri Plaque ID Gel™ (D0470042731)

GUDID

Device Identifier (DI) Information

Brand Name: GC Tri Plaque ID Gel™
Version or Model: 004273
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 004273
Company Name: Gc America Inc.

Primary DI Number: D0470042731
Issuing Agency: HIBCC
Commercial Distribution End Date: August 06, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: GC Tri Plaque ID Gel™ 40g tube (36 mL, approximately 130 applications)

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?
60408	Dental caries detecting stain	A liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NYH	plaque disclosing kit

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
Storage Environment Temperature: between 8 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 40 Gram

Device Record Status

Public Device Record Key: 6c322195-34b3-4301-8e8a-1a8379691ce2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 01, 2016