Honigum Pro Mono 989568

GUDID EDMG9895688

Impression material, medium-bodied consistency. Impressions made your way. Content: 1 cartridge @ 380 ml paste, Accessories

DMG Chemisch-Pharmazeutische Fabrik GmbH

Silicone dental impression material
Primary Device IDEDMG9895688
NIH Device Record Key10956d52-d89f-4a9a-ab33-58b72e6e25f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHonigum Pro Mono
Version Model Number989568
Catalog Number989568
Company DUNS320744915
Company NameDMG Chemisch-Pharmazeutische Fabrik 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 Numbertrue
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

Phone201-894-5505
Emaileanagnostos@dmg-america.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDMG9895680 [Primary]
HIBCCEDMG9895681 [Package]
Contains: EDMG9895680
Package: [1 Units]
In Commercial Distribution
HIBCCEDMG9895688 [Package]
Contains: EDMG9895681
Package: [6 Units]
In Commercial Distribution

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [Honigum Pro Mono]

EDMG9898308Impression material, medium-bodied consistency. Impression made your way. Content: 4 cartridges
EDMG9895688Impression material, medium-bodied consistency. Impressions made your way. Content: 1 cartridge

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.