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
Rx
false
OTC
true
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852421007874Pure&Clean2025.121WC4-RXP2026-02-27
00852421007867Pure&Clean2025.112025-12-12
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
00852421007546Pure&Clean 2-25-2011WC16-ZRX2023-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365197409105A+D Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.FRO2026-05-25
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10885632434266HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468490HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468506HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468513HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468520HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509032HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509049HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509056HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509063HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632510199HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
06977727072211Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072228Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072235Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072242Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072419SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072426SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072433SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072440SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
00050428339770CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-03-20
04719883980090Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980311Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980342Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980359Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980366Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980373Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980380Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980397Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
05060996770023AcutarexAlliance Healing Technologies, LLCFRO2026-03-13