FDA.reportPublic FDA data

Citrizyme 300g

Primary DI
00310866000015
Brand
Citrizyme 300g
Company
PASCAL COMPANY, INC.
Model
15250
Catalog number
15250
Device description
Ultra Concentrated Enzymatic Evacuation Cleaner and Instrument Pre-Soak With the Deodorizing Power of Baking Soda.Orange Scented; Dual Enzymes; Non-Corrosive; Non-Foaming; Biodegradable; Non-Toxic; Makes 35 gallons of cleaner. 300g Pouch
Published
2019-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDZCleaners, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDZCleaners, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00310866000015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00310866000015003108660000153108660000150310866000015

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-426-8051pascaldental@pascaldental.com

Regulatory Flags#

DUNS number
009260217
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00310866000732Retrax Cord Cutter26440264402019-01-24
00310866002552KOIS KR-1 PACKER262252024-06-04
00310866002606KOIS KR-2 PACKER262262024-06-04
00310866002613KOIS KR-3 PACKER262272024-06-04
00310866002620KOIS KR-4 PACKER262282024-06-04
00310866002637KOIS KR-5 PACKER262292024-06-04
00310866002644GET SCULPTED26-31026-3102024-05-16
00310866002651Fluorilaq Salted Caramel (10mL) Tube104022024-03-28
00310866002668Fluorilaq Mint (10mL) Tube104062024-03-28
00310866002408Racord Plus Retraction Cord 7/0007797077972021-11-22
00310866002415Racord Plus Retraction Cord 8/007800078002021-11-22
00310866002422Racord Plus Retraction Cord 9/107810078102021-11-22
00310866002439Racord Plus Retraction Cord 10/207820078202021-11-22
00310866000800Retrax Pellets12400124002019-01-31
00310866000275KnitTrax Plain Retraction Cord 00007569075692019-01-29
00310866000282KnitTrax Plain Retraction Cord 0007570075702019-01-29
00310866000299KnitTrax Plain Retraction Cord 007575075752019-01-29
00310866000305KnitTrax Plain Retraction Cord 107580075802019-01-29
00310866000312KnitTrax Plain Retraction Cord 207585075852019-01-29
00310866000329SilTrax AS Retraction Cord 7/0007097070972019-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00310866000046Citrizyme Ultra Concentrated Enzyme Powder 250 Packets PASCAL COMPANY, INC.MDZ2019-01-29
00310866000022Citrizyme Ultra Concentrated Enzyme Powder 50 PouchesPASCAL COMPANY, INC.MDZ2019-01-24
00310866000039Citrizyme Ultra Concentrated Enzymatic Powder 900gPASCAL COMPANY, INC.MDZ2019-01-24
00792293070036"Urocare® Urinary & Ostomy Appliance Cleaning Brush 8"" (20cm)"UROCARE PRODUCTS, INC.MDZ2018-06-01
00792293702043Urolux® Urinary and Ostomy Appliance Cleanser & Deodorant, Trial 4 oz. (118 mL.)UROCARE PRODUCTS, INC.MDZ2018-06-01
00792293702166Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.)UROCARE PRODUCTS, INC.MDZ2018-06-01
00792293985095Uro-Kit® Reusable Latex Leg Bag System 9 oz.UROCARE PRODUCTS, INC.MDZ2018-04-10
00792293985101Uro-Kit® Reusable Latex Leg Bag System 10 oz.UROCARE PRODUCTS, INC.MDZ2018-04-10
00792293985163Uro-Kit® Reusable Latex Leg Bag System 16 oz.UROCARE PRODUCTS, INC.MDZ2018-04-10
00792293985187Uro-Kit® Reusable Latex Leg Bag System 18 oz.UROCARE PRODUCTS, INC.MDZ2018-04-10
00792293985262Uro-Kit® Reusable Latex Leg Bag System 26 oz.UROCARE PRODUCTS, INC.MDZ2018-04-10
00792293985323Uro-Kit® Reusable Latex Leg Bag System 32 oz.UROCARE PRODUCTS, INC.MDZ2018-04-10
00792293995100Uro-Kit® Reusable Latex Leg Bag System 10 oz.UROCARE PRODUCTS, INC.MDZ2018-04-10
00792293995162Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.)UROCARE PRODUCTS, INC.MDZ2018-04-09
00792293995261Uro-Kit® Reusable Latex Leg Bag System 26 oz.UROCARE PRODUCTS, INC.MDZ2018-04-09
00792293995322Uro-Kit® Reusable Latex Leg Bag System 32 oz.UROCARE PRODUCTS, INC.MDZ2018-04-09
00792293995445Uro-Kit® Reusable Latex Leg Bag System 44 oz.UROCARE PRODUCTS, INC.MDZ2018-04-09
08033837931331mocomCEFLA SOCIETA' COOPERATIVAMDZ2016-12-01