Tulip ColorSwitch AA371

GUDID E241AA3711

Dental Alginate Impression material

Cavex Holland B.V.

Alginate dental impression material
Primary Device IDE241AA3711
NIH Device Record Keyc24cc379-24d8-4e5f-8198-dd2c682a25d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTulip ColorSwitch
Version Model NumberAA371
Catalog NumberAA371
Company DUNS419980156
Company NameCavex Holland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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+31(0)235307700
Emailr.woortman@cavex.nl

Device Dimensions

Weight10.8 Kilogram

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE241AA3711 [Primary]

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-06-09

On-Brand Devices [Tulip ColorSwitch]

E241AA3711Dental Alginate Impression material
E241AA3710Dental Alginate Impression material

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