Drufosoft® D4248X20

GUDID E239D4248X201

No.

Dreve Dentamid GmbH

Dental appliance fabrication material, thermoplastic
Primary Device IDE239D4248X201
NIH Device Record Key69def1c5-3971-4d45-8c4a-509f92e7a509
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrufosoft®
Version Model NumberD4248X20
Catalog NumberD4248X20
Company DUNS388000846
Company NameDreve Dentamid 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 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

Customer Support Contacts

Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE239D4248X201 [Primary]

FDA Product Code

KMYPOSITIONER, TOOTH, PREFORMED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-19

On-Brand Devices [Drufosoft®]

E239D42531SQ1No.
E239D425311No.
E239D4252SQ1No.
E239D42521No.
E239D42511SQ1No.
E239D42511S1No.
E239D42501No.
E239D4249011No.
E239D4248X9SQ1No.
E239D4248X91No.
E239D4248X81No.
E239D4248X71No.
E239D4248X6S1No.
E239D4248X61No.
E239D4248X51No.
E239D4248X41No.
E239D4248X3Q1No.
E239D4248X31No.
E239D4248X26SQ1No.
E239D4248X261No.
E239D4248X251No.
E239D4248X24S1No.
E239D4248X241No.
E239D4248X23SQ1No.
E239D4248X231No.
E239D4248X221No.
E239D4248X21SQ1No.
E239D4248X211No.
E239D4248X21No.
E239D4248X201No.
E239D4248X191No.
E239D4248X18SQ1No.
E239D4248X18S1No.
E239D4248X181No.
E239D4248X17SQ1No.
E239D4248X171No.
E239D42483X91No.
E239D42483X81No.
E239D42483X71No.
E239D42483X61No.
E239D42483X51No.
E239D42483X41No.
E239D42483X31No.
E239D42483X261No.
E239D42483X251No.
E239D42483X241No.
E239D42483X231No.
E239D42483X221No.
E239D42483X211No.
E239D42483X21No.

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