Dental impression material (Private Label) D91611004

GUDID E239D916110041

No.

Dreve Dentamid GmbH

Silicone dental impression material
Primary Device IDE239D916110041
NIH Device Record Keyef5872ca-43e0-473e-a87b-891e37bbb09e
Commercial Distribution Discontinuation2020-01-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDental impression material (Private Label)
Version Model NumberD91611004
Catalog NumberD91611004
Company DUNS388000846
Company NameDreve Dentamid GmbH
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE239D916110041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-27
Device Publish Date2016-12-08

On-Brand Devices [Dental impression material (Private Label)]

E239HFPD05191No.
E239HFPD02941No.
E239HFPD02871No.
E239HFPD01751No.
E239HFPD01381No.
E239D916110051No.
E239D916110041No.
E239D907170071No.
E239D907170061No.
E239D907170051No.
E239D907110031No.
E239D907110021No.
E239D7485N1No.
E239D507701601No.

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