AccessGUDID - DEVICE: Darby Dental Supply, LLC (00889813051443)

GUDID

Device Identifier (DI) Information

Brand Name: Darby Dental Supply, LLC
Version or Model: 5251887
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5251887
Company Name: DARBY DENTAL SUPPLY, LLC

Primary DI Number: 00889813051443
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 48
Labeler D-U-N-S® Number*: 825137818 *Terms of Use

Device Description: TMIX C&B TIP 1:1 BLUE/WHITE

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:	Yes
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?
38790	Dental impression material mixer	A mains electricity (AC-powered) device designed for mixing to produce a dental impression material chairside immediately before application to the oral cavity of a patient during a dental procedure. It is typically used to blend a salt of alginic acid (i.e., alginate) with water (and appropriate additives if necessary) to produce a dental impression material of rapid irreversible setting. The device typically consists of an electrical mixer with a well, a container (e.g., cup) used to mix the alginate with water before placing in the mixer well, and external controls to operate the mixer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e62495a6-a5cc-4ddd-83c3-855b873c50d1
Public Version Date: March 01, 2021
Public Version Number: 1
DI Record Publish Date: February 19, 2021