TriPhasix™ S400

GUDID M595S4043

1lb. TriPhasix™ Chromatic Alginate

PARKELL, INC.

Silicone dental impression material
Primary Device IDM595S4043
NIH Device Record Key23b45f9d-94eb-41b9-ba23-94a5e2874802
Commercial Distribution Discontinuation2019-01-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTriPhasix™
Version Model NumberS400
Catalog NumberS400
Company DUNS009900424
Company NamePARKELL, INC.
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 Usetrue
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

Phone6312491134
Emailcustomerservice@parkell.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep container tightly closed and store in a cool, dry and well-ventilated place.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep container tightly closed and store in a cool, dry and well-ventilated place.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM595S4000 [Primary]
HIBCCM595S4011 [Package]
Contains: M595S4000
Package: [5 Units]
Discontinued: 2019-01-01
Not in Commercial Distribution
HIBCCM595S4022 [Package]
Contains: M595S4000
Package: [10 Units]
Discontinued: 2019-01-01
Not in Commercial Distribution
HIBCCM595S4043 [Package]
Contains: M595S4000
Package: [25 Units]
Discontinued: 2019-01-01
Not in Commercial Distribution

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 Date2019-04-01
Device Publish Date2016-09-23

On-Brand Devices [TriPhasix™]

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

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