AccessGUDID - DEVICE: BULK 35% Calcium Hydroxide Paste 4pk Kit (07540172010580)

GUDID

Device Identifier (DI) Information

Brand Name: BULK 35% Calcium Hydroxide Paste 4pk Kit
Version or Model: 872001
Catalog Number: 872001
Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Primary DI Number: 07540172010580
Issuing Agency: GS1
Device Count: 1

Device Description: Calcium Hydroxide Suspension

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Calcium hydroxide suspension	A very basic (high pH) calcium hydroxide (Ca(OH)2) solution (also known as slaked lime or milk of lime) used in dentistry for a variety of purposes including to flush and disinfect root canals and crowns/bridges before final insertion, and to change the viscosity and/or moisten a temporary tooth filling material. It may also encourage the change of fibroblasts (cells which form the connective tissue of the body) into odontoblast-like cells to produce reparative dentin. After application, this device cannot be reused.

GMDN Preferred Term Name

GMDN Definition

Calcium hydroxide suspension

A very basic (high pH) calcium hydroxide (Ca(OH)2) solution (also known as slaked lime or milk of lime) used in dentistry for a variety of purposes including to flush and disinfect root canals and crowns/bridges before final insertion, and to change the viscosity and/or moisten a temporary tooth filling material. It may also encourage the change of fibroblasts (cells which form the connective tissue of the body) into odontoblast-like cells to produce reparative dentin. After application, this device cannot be reused.

FDA Product Code

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Product Code	Product Code Name
EJK	LINER, CAVITY, CALCIUM HYDROXIDE
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 4x1.2ml syringe
Total Volume: 1.2 Milliliter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 16, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: BULK 35% Calcium Hydroxide Paste 4pk Kit (07540172010580)