FDA.reportPublic FDA data

Pure&Clean

Primary DI
00852421007447
Brand
Pure&Clean
Company
Pure & Clean, LLC
Model
22.12
Catalog number
4LP2-G
Device description
Pure&Clean Vision Source Lip Prep Hydrogel, 2 oz/59 ml
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852421007447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852421007447008524210074478524210074470852421007447

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid solutionA fluid material intended to be applied to the eyelids for various therapeutic ocular applications that typically include provision of supplemental lipids on the eyelid margin to stabilize the natural tear film lipid layer in the treatment of tear film deficiencies (e.g., dry eye syndrome), or to clean the eyelid or eyelid margin in the treatment of blepharitis and/or meibomian gland dysfunction. It is typically a liposomal (e.g., phospholipid) suspension or a saline solution, and is intended for use in the home or healthcare facility (single dose or multidose). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Fluid Ounce

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
417-243-0000info@pncvision.com

Regulatory Flags#

DUNS number
045315650
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852421007874Pure&Clean2025.121WC4-RXP2026-02-27
00852421007867Pure&Clean2025.112025-12-12
00852421007225Pure&Clean 19.081HG32023-08-04
00739189359158Pure&Clean None1WC82023-08-08
00852421007331Pure&Clean 22.063HP22023-08-11
00852421007348Pure&Clean 23.033HP82023-08-11
00852421007461Pure&Clean 22.084HP82023-08-11
00852421007577Pure&Clean None4HP22023-08-11
00852421007669Pure&Clean 2020.031HC22023-08-11
00852421007676Pure&Clean 2020.041HC82023-08-11
00852421007720Pure&Clean 2020.084HPG2023-08-11
00852421007737Pure&Clean 2020.081HCG2023-08-11
00852421007386Pure&Clean 2-25-2011WC16-ZRXP2023-08-08
00852421007393Pure&Clean None11WC16-ZRXI2023-08-08
00852421007409Pure&Clean194WC4RX-211WC4-ZRX2023-08-08
00852421007492Pure&Clean None11VC2-Z2023-08-08
00852421007508Pure&Clean 2-25-2011WC2-Z2023-08-08
00852421007515Pure&Clean 2-25-2011WC8-Z2023-08-08
00852421007522Pure&Clean 194HG3-211HG3-Z2023-08-08
00852421007539Pure&Clean None11HG8-Z2023-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990802Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990895Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
10884389161562MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-06
00361470000175Amerigel Saline Wound WashAmerx Health Care Corp.FRO2026-06-22
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
00050428453599CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz TubeSion Brands LLCFRO2026-06-01