FDA.reportPublic FDA data

ProCure

Primary DI
10840330703168
Brand
ProCure
Company
Twin Med, LLC
Model
PCHCA44
Catalog number
PCHCA44
Device description
"ProCure - Calcium Alginate 4.25""x 4.25"" - 10ea/bx 40bx/cs"
Published
2023-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840330703162PackageGS110In Commercial Distribution
50840330703166PackageGS140In Commercial Distribution
10840330703168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070316230840330703162
5084033070316650840330703166
1084033070316810840330703168

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.25Inch
Width4.25Inch

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
804-776-2873xx@xx.xx

Regulatory Flags#

DUNS number
107071289
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840330702208ProCurePC650CBPC650CB2026-06-01
10840330702215ProCurePC660CBPC660CB2026-06-01
10840330702222ProCurePC670CBPC670CB2026-06-01
10840330702239ProCurePC680CBPC680CB2026-06-01
10840330702246ProCurePC690CBPC690CB2026-06-01
10840330702024ProCurePC600CBPC600CB2026-05-29
10840330702062ProCurePC610CBPC610CB2026-05-29
10840330702109ProCurePC620CBPC620CB2026-05-29
10840330702147ProCurePC630CBPC630CB2026-05-29
10840330702185ProCurePC640CBPC640CB2026-05-29
10840330702765ProCurePC860PC8602026-07-08
10840330706756ProCurePC600CB-APC600CB-A2026-06-01
10840330706763ProCurePC610CB-APC610CB-A2026-06-01
10840330706770ProCurePC620CB-APC620CB-A2026-06-01
10840330706787ProCurePC630CB-APC630CB-A2026-06-01
10840330706794ProCurePC640CB-APC640CB-A2026-06-01
10840330702000ProCurePC600BLKPC600BLK2026-05-29
10840330702048ProCurePC610BLKPC610BLK2026-05-29
10840330702086ProCurePC620BLKPC620BLK2026-05-29
10840330702123ProCurePC630BLKPC630BLK2026-05-29

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Primary DI, Brand, Company table
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10197344175963MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175970MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175987MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
00850088144314CARBOUNingbo kehu Medical Technology Co.,Ltd.NAC2026-07-08
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00197998295850Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295898Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295942Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
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09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940052DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940069DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940076DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940083DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940090DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940106DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22