FDA.reportPublic FDA data

PuraPly™ Antimicrobial XT Wound Matrix

Primary DI
00061874000282
Brand
PuraPly™ Antimicrobial XT Wound Matrix
Company
ORGANOGENESIS INC.
Model
515-036
Device description
PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
Published
2019-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00061874000282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00061874000282000618740002820618740002820061874000282

GMDN Terms#

Term, Definition table
TermDefinition
Collagen dressingA sterile, bioabsorbable, collagen protein matrix, animal-derived, designed to provide an occlusive/semi-occlusive cover for a wound, primarily to maintain a clean and moist environment for healing. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, or surgical wounds. It may combine collagen with 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
Length6Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to temperatures above 120 degrees fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
152165817
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
05059884011188Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
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