AccessGUDID - DEVICE: Henry Schein (00304040005101)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 1011747
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1011747
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040005101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: ZOE Temporary Cement

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

GMDN Preferred Term Name	GMDN Definition
Temporary dental filling material	A dental material of various chemical compositions [e.g., calcium hydroxide (Ca(OH)2), methyl methacrylate] used to temporarily fill tooth cavities to preserve the tooth and its pulp. It is typically x-ray visible and may be used for temporary tooth filling with direct/indirect capping, root treatment with pulp capping, vital amputations, treatment of extirpation, decayed pulps, gangrene, fistulae, sensitive tooth crevices, superficial enamel caries, and marginal periodontium inflammation. After application, this device cannot be reused.

GMDN Preferred Term Name

GMDN Definition

Temporary dental filling material

A dental material of various chemical compositions [e.g., calcium hydroxide (Ca(OH)2), methyl methacrylate] used to temporarily fill tooth cavities to preserve the tooth and its pulp. It is typically x-ray visible and may be used for temporary tooth filling with direct/indirect capping, root treatment with pulp capping, vital amputations, treatment of extirpation, decayed pulps, gangrene, fistulae, sensitive tooth crevices, superficial enamel caries, and marginal periodontium inflammation. After application, this device cannot be reused.

FDA Product Code

[?]

Product Code	Product Code Name
EMB	ZINC OXIDE EUGENOL

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 10 and 24 Degrees Celsius
Storage Environment Temperature: between 10 and 75 Degrees Fahrenheit
Special Storage Condition, Specify: Keep out of sun

Clinically Relevant Size

[?]

Size Type Text
Weight: 45 Gram
Device Size Text, specify: Catalyst
Weight: 20 Gram
Device Size Text, specify: Base

Device Record Status

Public Device Record Key: a62f06ef-85cf-4cb3-b627-7d9840062c14
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016