P pro Try-In 019.3117

GUDID 04260635980207

P pro Try-In 1000g

DeltaMed GmbH

Dental base plate
Primary Device ID04260635980207
NIH Device Record Keye37dbbd0-f8b3-44db-83f1-4d9a026abfd1
Commercial Distribution StatusIn Commercial Distribution
Brand NameP pro Try-In
Version Model Number019.3117
Catalog Number019.3117
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104260635980207 [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 Date2022-02-21
Device Publish Date2022-02-11

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EDEL16131500 - 3Delta UNlimited2025-03-24 3Delta UNlimited Bleach 500g
EDEL16131550 - 3Delta UNlimited2025-03-24 3Delta UNlimited B1 500g
EDEL16131600 - 3Delta UNlimited2025-03-24 3Delta UNlimited C1 500g
EDEL16132100 - 3Delta UNlimited2025-03-24 3Delta UNlimited A1 1000g

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