AccessGUDID - DEVICE: Darby Dental Supply, LLC (00889813001035)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: FP-DARBY-054
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9521060
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 00889813001035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: Zinc Phosphate Cement Liquid 15 ml

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?
38778	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.	Obsolete	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
Storage Environment Temperature: between 59 and 75 Degrees Fahrenheit
Special Storage Condition, Specify: Keep out of sun

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 15 Milliliter

Device Record Status

Public Device Record Key: f86c9cec-7ae1-4224-b7b5-2d300d6bdeaa
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 08, 2016