Candid Redo Impression Kit

GUDID 00850004223079

Redo Impression Kit (large trays)

CANDID CARE CO.

Silicone dental impression material
Primary Device ID00850004223079
NIH Device Record Keyaf908b19-34eb-4120-aded-d08cd6989449
Commercial Distribution StatusIn Commercial Distribution
Brand NameCandid Redo Impression Kit
Version Model NumberRDLGORANGE00001
Company DUNS108729170
Company NameCANDID CARE CO.
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9177542056
Emaildan.michaeli@candidco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004223079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIGRetractor, All Types

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-03-01

On-Brand Devices [Candid Redo Impression Kit]

00850004223093Redo Impression Kit (small Trays)
00850004223086Redo Impression Kit (medium trays)
00850004223079Redo Impression Kit (large trays)
00850004223062Candid redo impression (medium trays)
00850004223055Redo Impression Kit RDMDPAT00001 (Medium Trays)
00850004223048Candid Redo Impression Kit (small trays)
00850004223031Redo Impression Kit (Large Trays)
00850004223154Redo Impression Kit (Large Trays) Kett Putty Digital
00850004223147Redo Impression Kit (Medium Trays) Kett Putty Digital
00850004223130Redo Impression Kit (Small Trays) Kett Putty Digital

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