FDA.reportPublic FDA data

PuraPly Antimicrobial XT Wound Matrix

Primary DI
00618474000466
Brand
PuraPly Antimicrobial XT Wound Matrix
Company
ORGANOGENESIS INC.
Model
515-071
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
2021-12-01
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
00618474000466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618474000466006184740004666184740004660618474000466

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
Length4.91Centimeter
Width4.91Centimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-432-5232MEDINFO@ORGANO.COM

Regulatory Flags#

DUNS number
152165817
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00618474000411PuraPly Micronized Wound Matrix (PuraPly MZ) 515-063 2023-05-01

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Primary DI, Brand, Company table
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