Dispersed Phase Alloy CAP Regular Set 1 SPILL 9526830

GUDID 20889813001534

Dispersed Phase Alloy CAP Regular Set 1 SPILL

DARBY DENTAL SUPPLY, LLC

Dental amalgam
Primary Device ID20889813001534
NIH Device Record Key0f1eb250-1bd2-4311-923c-41e3419cea5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDispersed Phase Alloy CAP Regular Set 1 SPILL
Version Model Number9526830
Catalog Number9526830
Company DUNS825137818
Company NameDARBY DENTAL SUPPLY, LLC
Device Count500
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com
Phone+1(516)688-6800
EmailRobyn.livingston@darby.com

Device Dimensions

Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram
Device Size Text, specify0
Weight400 Milligram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool well-ventilated place
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100889813001530 [Unit of Use]
GS120889813001534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJJAlloy, amalgam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-06-24

On-Brand Devices [Dispersed Phase Alloy CAP Regular Set 1 SPILL]

20889813001534Dispersed Phase Alloy CAP Regular Set 1 SPILL
10889813001537Dispersed Phase Alloy CAP Regular Set 1 SPILL

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