Acu-Flow™ Heavy Body 1-016402

GUDID 07540172017428

Hydrophillic Impression Material

CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material
Primary Device ID07540172017428
NIH Device Record Key9a701801-9379-43d2-875f-14a2dd7ec77a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcu-Flow™ Heavy Body
Version Model Number1-016402
Catalog Number1-016402
Company DUNS626406016
Company NameCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Device Count1
DM Exempttrue
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

Customer Support Contacts

Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com

Device Dimensions

Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0
Total Volume300 Milliliter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 17 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540172017428 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31