TriPhasix™ S403

GUDID 10810000526182

Measuring Scoops TriPhasix™ Alginate (2 each)

PARKELL, INC.

Alginate dental impression material
Primary Device ID10810000526182
NIH Device Record Key8998d10e-f5f2-40a4-a1ad-c8172f3ec98e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriPhasix™
Version Model NumberS403
Catalog NumberS403
Company DUNS009900424
Company NamePARKELL, INC.
Device Count2
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6312491134
Emailcustomerservice@parkell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000526185 [Unit of Use]
GS110810000526182 [Primary]

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 Date2020-02-17
Device Publish Date2020-02-07

On-Brand Devices [TriPhasix™]

308100005261551lb. TriPhasix™ Chromatic Alginate
M595S40431lb. TriPhasix™ Chromatic Alginate
10810000526182Measuring Scoops TriPhasix™ Alginate (2 each)
00810000528271Measuring Scoops TriPhasix™ Alginate

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.