FDA.reportPublic FDA data

ProCure

Primary DI
30840330703308
Brand
ProCure
Company
Twin Med, LLC
Model
PCHO3008
Catalog number
PCHO3008
Device description
ProCure - Oil Emulsion Non Adhering Dressing 3"x8" 24ea/bx 24bx/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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840330703308PackageGS124In Commercial Distribution
50840330703302PackageGS124In Commercial Distribution
10840330703304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070330830840330703308
5084033070330250840330703302
1084033070330410840330703304

GMDN Terms#

Term, Definition table
TermDefinition
Pressure-ulcer topical dressingA solution or emulsion designed to be applied to dermal pressure sores to prevent and treat pressure/decubitus ulcers and lower extremity ulcers. It is composed of natural materials (e.g., ozonized olive oil, sunflower oil, and/or other plant extracts) intended primarily to create a barrier between the skin lesion(s) and the external environment to promote protection and healing. The solution/emulsion is typically dispensed from a spray bottle or other container. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch
Width3Inch

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
true
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
00612479282179McKessonMCKESSON MEDICAL-SURGICAL INC.NAD2026-03-17
06974795053920MEDLOTHenan Maidingkang Medical Technology Co., Ltd.NAD2026-03-13
30885632495469HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495851HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495868HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495875HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495882HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496742HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496766HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
06974843740574MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740581MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740598MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740604MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740741MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740758MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740765MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740772MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740789MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740796MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740802MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740819MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740826MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740833MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740840MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740857MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740864MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740871MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740888MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740895MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740901MemGardDalian Orientech Co.,LtdNAD2026-03-10