Original D Powder Ex Fast Set 5 oz

GUDID 00853383006967

Wykle Research, Inc

Dental amalgam
Primary Device ID00853383006967
NIH Device Record Keyd69a8b1d-b7c7-44bf-a622-de2036a2528e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOriginal D Powder Ex Fast Set 5 oz
Version Model Number19305
Company DUNS614557155
Company NameWykle Research, Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853383006967 [Primary]

FDA Product Code

OIVDental 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 Date2016-11-28

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

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