3Delta Try-In 1621120

GUDID EDEL16211200

3Delta Try-In 1000g

DeltaMed GmbH

Dental base plate
Primary Device IDEDEL16211200
NIH Device Record Keyf3f4dd23-e7a7-424c-8873-23d8982fd850
Commercial Distribution StatusIn Commercial Distribution
Brand Name3Delta Try-In
Version Model Number1621120
Catalog Number1621120
Company DUNS344805101
Company NameDeltaMed GmbH
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 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDEL16211200 [Primary]

FDA Product Code

EEAPlate, Base, Shellac

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-08
Device Publish Date2022-01-31

On-Brand Devices [3Delta Try-In]

EDEL162112003Delta Try-In 1000g
EDEL162111003Delta Try-In 500g

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