FDA.reportPublic FDA data

PuraPly Antimicrobial Surgical Wound Matrix

Primary DI
00618474000534
Brand
PuraPly Antimicrobial Surgical Wound Matrix
Company
ORGANOGENESIS INC.
Model
515-073
Device description
PuraPly Antimicrobial Surgical Wound Matrix is a cross-linked extracellular matrix (ECM) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly Antimicrobial Surgical Wound Matrix is supplied in a dry sheet form. The device is packaged in sterile, sealed single pouches.
Published
2026-03-12
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

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
00618474000534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618474000534006184740005346184740005340618474000534

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
Length8Centimeter
Width16Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze or expose to excessive heat

Sterilization Methods#

Method table
Method

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
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
00618474000411PuraPly Micronized Wound Matrix (PuraPly MZ) 515-063 2023-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850039735363MendER Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00850039735370TG-32 Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00850039735387TG-32 Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00850039735394MendER Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00197998307386Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
00197998307423Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
00197998307461Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
10080196299850MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-10-22
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
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05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09