FDA.reportPublic FDA data

ProCure

Primary DI
30840330703391
Brand
ProCure
Company
Twin Med, LLC
Model
PCHX3004
Catalog number
PCHX3004
Device description
ProCure - Xeroform Petrolatum Dressing 4"x4" 25ea/bx 40bx/cs
Published
2023-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
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
30840330703391PackageGS125In Commercial Distribution
50840330703395PackageGS140In Commercial Distribution
10840330703397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070339130840330703391
5084033070339550840330703395
1084033070339710840330703397

GMDN Terms#

Term, Definition table
TermDefinition
Petrolatum woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates; it is not however a dedicated burn dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch
Width4Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry, Avoid Freezing & Direct Sunlight
Storage Environment Temperature32 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-819-1635sanderson@twinmed.com

Regulatory Flags#

DUNS number
107071289
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30840330705869ProCurePCHCB002PCHCB0022025-11-26
30840330705876ProCurePCHCB002LPCHCB002L2025-11-26
30840330705883ProCurePCHCB004PCHCB0042025-11-26
30840330705890ProCurePCHWCS183PCHWCS1832025-11-26
30840330705906ProCurePCHWCS1415PCHWCS14152025-11-26
30840330705913ProCurePCHWCS144PCHWCS1442025-11-26
30840330705920ProCurePCHWCS124PCHWCS1242025-11-26
30840330705937ProCurePCHWCS143PCHWCS1432025-11-26
30840330701731ProCurePCKDK20PCKDK202025-05-31
30840330701748ProCurePCKDC20PCKDC202025-05-31
30840330701755ProCurePCCIT10PCCIT102025-05-31
30840330701762ProCurePCCIT30PCCIT302025-05-31
30840330701779ProCurePCUCIT14PCUCIT142025-05-31
30840330701786ProCurePCUCIT14RPCUCIT14R2025-05-31
30840330701793ProCurePCDB20HPCDB20H2025-05-31
30840330701809ProCurePCDB20PCDB202025-05-31
30840330701557ProCurePCHTF22PCHTF222025-04-17
30840330705425ProCure100897010089702025-01-20
30840330701816ProCurePC700PC7002024-11-21
30840330701823ProCurePC710PC7102024-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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