Wykalloy Capsules 2 Spill 500 count

GUDID 00853383006073

Wykle Research, Inc

Dental amalgam
Primary Device ID00853383006073
NIH Device Record Key8abc6517-182c-4a36-aa66-bcd25d82f8f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameWykalloy Capsules 2 Spill 500 count
Version Model Number73400
Company DUNS614557155
Company NameWykle Research, Inc
Device Count1
DM Exemptfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853383006073 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Wykle Research, Inc

00853383006011 - Original D Capsules 1 Spill Fast Set 50 count2018-07-12
00853383006158 - Original D Tablets Fast Set 10 oz2018-07-12
00853383006202 - Original D Capsules 2 Spill Fast Set 100 count2018-07-12
00853383006035 - Wykalloy Capsules 1 Spill 50 count2018-07-06
00853383006042 - Wykalloy Capsules 2 Spill 50 count2018-07-06
00853383006059 - Wykalloy Capsules 3 Spill 50 count2018-07-06
00853383006066 - Wykalloy Capsules 1 Spill 500 count2018-07-06
00853383006073 - Wykalloy Capsules 2 Spill 500 count2018-07-06
00853383006073 - Wykalloy Capsules 2 Spill 500 count2018-07-06

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