FDA.report

Pure&Clean

Primary DI
00852421007331
Brand
Pure&Clean
Company
Pure & Clean, LLC
Model
22.06
Catalog number
3HP2
Device description
Hand Prep 2 oz
Published
2023-08-11
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

Related Records

Contact Domains

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00852421007331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00852421007331008524210073318524210073310852421007331

GMDN Terms

TermDefinition
Antimicrobial wound irrigation solutionA solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Total Volume2Fluid Ounce

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
00852421007874Pure&Clean2025.121WC4-RXP2026-02-27
00852421007867Pure&Clean2025.112025-12-12
00739189359158Pure&Clean None1WC82023-08-08
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
00852421007553Pure&Clean 2-24-2011WCQ-ZRX2023-08-08

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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
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04719883980397Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
05060996770023AcutarexAlliance Healing Technologies, LLCFRO2026-03-13
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00618474000299PuraPly Antimicrobial Wound MatrixORGANOGENESIS INC.FRO2026-03-12
00618474000305PuraPly Antimicrobial Wound MatrixORGANOGENESIS INC.FRO2026-03-12
00618474000312PuraPly Antimicrobial Wound MatrixORGANOGENESIS INC.FRO2026-03-12
00618474000329PuraPly Antimicrobial Wound MatrixORGANOGENESIS INC.FRO2026-03-12
00618474000497PuraPly Antimicrobial Surgical Wound MatrixORGANOGENESIS INC.FRO2026-03-12
00618474000503PuraPly Antimicrobial Surgical Wound MatrixORGANOGENESIS INC.FRO2026-03-12
00618474000534PuraPly Antimicrobial Surgical Wound MatrixORGANOGENESIS INC.FRO2026-03-12
00618474000541PuraPly Antimicrobial Surgical Wound MatrixORGANOGENESIS INC.FRO2026-03-12