FDA.reportPublic FDA data

ProCure

Primary DI
10840330706176
Brand
ProCure
Company
Twin Med, LLC
Model
PCHCMDS44
Catalog number
PCHCMDS44
Device description
"ProCure Healing AG Collagen Matrix Dressing with Silver 4""x4"" - 10ea/bx 10bx/cs"
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060804000COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSINGCovalon Technologies, Ltd.2006-04-18FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840330706170PackageGS110In Commercial Distribution
50840330706174PackageGS110In Commercial Distribution
10840330706176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070617030840330706170
5084033070617450840330706174
1084033070617610840330706176

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height10Centimeter
Length10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and away from direct sunlight
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
107071289
Device count
1
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
10840330700259Procure010-104858010-1048582022-11-02
10840330700266Procure100224810022482022-11-02
10840330700273Procure100228310022832022-11-02
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

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00850087488723CeeportCEEPORT INC.FRO2026-08-26
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10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
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00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
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10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29