FDA.reportPublic FDA data

PuraPly™ Antimicrobial Wound Matrix

Primary DI
00618474000084
Brand
PuraPly™ Antimicrobial Wound Matrix
Company
ORGANOGENESIS INC.
Model
515-014
Device description
PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
Published
2016-03-18
Public version status
Update
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
K051647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051647000FORTADERM ANTIMICROBIAL WOUND DRESSINGOrganogenesis, Inc.2005-11-08FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00618474000084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618474000084006184740000846184740000840618474000084

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Centimeter
Width2Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to temperatures above 120 degrees fahrenheit
Special Storage Condition, Specify00Store in a clean, dry location at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-432-5232xx@xx.xx

Regulatory Flags#

DUNS number
152165817
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618474000466PuraPly Antimicrobial XT Wound Matrix515-0712021-12-01
00618474000169PuraPly Antimicrobial Wound Matrix515-0262026-03-12
00618474000176PuraPly Antimicrobial Wound Matrix515-0282026-03-12
00618474000183PuraPly Antimicrobial Wound Matrix515-0302026-03-12
00618474000190PuraPly Antimicrobial Wound Matrix515-0322026-03-12
00618474000299PuraPly Antimicrobial Wound Matrix515-0442026-03-12
00618474000305PuraPly Antimicrobial Wound Matrix515-0462026-03-12
00618474000312PuraPly Antimicrobial Wound Matrix515-0482026-03-12
00618474000329PuraPly Antimicrobial Wound Matrix515-0502026-03-12
00618474000497PuraPly Antimicrobial Surgical Wound Matrix515-0552026-03-12
00618474000503PuraPly Antimicrobial Surgical Wound Matrix515-0572026-03-12
00618474000534PuraPly Antimicrobial Surgical Wound Matrix515-0732026-03-12
00618474000541PuraPly Antimicrobial Surgical Wound Matrix515-0752026-03-12
00618474000442PuraPly™ Antimicrobial Wound Matrix515-0672021-04-06
00618474000039PuraPly™ Antimicrobial Wound Matrix12015-05-22
00618474000022PuraPly™ Wound Matrix12015-05-22
00618474000077PuraPly™ Wound Matrix 515-0122016-06-28
00618474000145PuraPly™ Wound Matrix 515-0242017-05-12
00618474000398PuraPly Micronized Wound Matrix (PuraPly MZ) 515-059 2023-05-01
00618474000404PuraPly Micronized Wound Matrix (PuraPly MZ) 515-061 2023-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28