Original D Capsules 2 Spill Extra Fast Set 500 count

GUDID 00853383006134

Wykle Research, Inc

Dental amalgam
Primary Device ID00853383006134
NIH Device Record Key256e6db5-6fb3-47cd-928a-790b2fd61d35
Commercial Distribution StatusIn Commercial Distribution
Brand NameOriginal D Capsules 2 Spill Extra Fast Set 500 count
Version Model Number61232-03
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 Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853383006134 [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 Date2016-09-23

On-Brand Devices [Original D Capsules 2 Spill Extra Fast Set 500 count]

0085338300619661242-03
0085338300613461232-03

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