FDA.reportPublic FDA data

PRIMUS STERILIZER COMPANY, LLC.

Matched from indexed company URL: PRIMUS CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19323551000119270PRIMUS STERILIZER COMPANY, LLC.1N2026-01-01175 N US HWY 281 Great Bend KS US 67530
30060528753006052875PRIMUS PHARMACEUTICALS, INC.1N2026-01-017373 N SCOTTSDALE RD STE B200 Scottsdale AZ US 85253
30305977973030597797PRIMUS Sterilizer Company LLC1N2026-01-01110 Tech Dr Sanford FL US 32771
19543043002961000PRIMUS STERILIZER COMPANY, LLC.1N2020-04-253707 North Main Street Great Bend KS US 67530

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05391516748100Trinity Biotech - Hemoglobin A1c assay, Premier Buffer B Reagent - 3.8L800-325-3424customerservice@trinityusa.com
05391516748117Trinity Biotech - Hemoglobin A1c assay, Premier Sample Diluent Reagent - 940mL800-325-3424customerservice@trinityusa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
134201763125539K991575PRIMUS STEAM STERILIZERSFLE1999-12-03
716391763125539K991575PRIMUS STEAM STERILIZERSFLE1999-12-03
3267211763125539K991575PRIMUS STEAM STERILIZERSFLE1999-12-03
134201671201545K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)FLE2023-12-19
3267211671201545K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)FLE2023-12-19
3267211386048397K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)FLE2023-02-10
134201386048397K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)FLE2023-02-10
134202004970955K093333PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8FLE2010-04-02
3267212004970955K093333PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8FLE2010-04-02
716392004970955K093333PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8FLE2010-04-02
716391813439490K082817PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-MFLE2009-05-21
3267211813439490K082817PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-MFLE2009-05-21
134201813439490K082817PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-MFLE2009-05-21
2180811153709372K052643EPICERAMFRO2006-04-11
2180812023404208K050158SINCLAIR SEBORRHEA EMULSIONFRO2006-10-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FLE162023-12-19
FRO22006-10-11

NDC#

Impoyz

Primus Pharmaceuticals, Inc.

clobetasol propionate

Sernivo

Primus Pharmaceuticals, Inc.

betamethasone dipropionate

PMN#

Applications#

GUDID#

Promiseb Topical Cream - Promiseb Topical Cream is an off-white, steroid-free, fragrance-free, water-based emulsion. Under the supervision of a healthcare professional, Promiseb Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Promiseb Topical Cream helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Primus Pharmaceuticals, Inc.

2026-05-01

EpiCeram® Skin Barrier Emulsion - EpiCeram® Skin Barrier Emulsion is a steroid free, fragrance free, ceramide dominant emulsion containing ceramide, conjugated linoleic acid (CLA), and cholesterol in a 3:1:1 ratio, respectively, in an emollient base. These lipids mimic those commonly found in skin. EpiCeram is used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, contact dermatitis (allergic and/or irritant), and radiation dermatitis. EpiCeram helps to relieve dry, waxy skin by maintaining a moist environment which aids the healing process.

Primus Pharmaceuticals, Inc.

2026-05-01

EpiCeram® Skin Barrier Emulsion - EpiCeram® Skin Barrier Emulsion is a steroid free, fragrance free, ceramide dominant emulsion containing ceramide, conjugated linoleic acid (CLA), and cholesterol in a 3:1:1 ratio, respectively, in an emollient base. These lipids mimic those commonly found in skin. EpiCeram is used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, contact dermatitis (allergic and/or irritant), and radiation dermatitis. EpiCeram helps to relieve dry, waxy skin by maintaining a moist environment which aids the healing process.

Primus Pharmaceuticals, Inc.

2026-05-01

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