PuraPly™ Antimicrobial Wound Matrix

GUDID 00618474000039

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.

ORGANOGENESIS INC.

Collagen wound matrix dressing
Primary Device ID00618474000039
NIH Device Record Key408042ba-afac-41de-9b01-682849f5a3b5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePuraPly™ Antimicrobial Wound Matrix
Version Model Number1
Company DUNS152165817
Company NameORGANOGENESIS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-432-5232
Emailxx@xx.xx
Phone1-888-432-5232
Emailxx@xx.xx

Device Dimensions

Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter
Area/Surface Area25 Square centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100618474000039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-06
Device Publish Date2015-05-22

On-Brand Devices [PuraPly™ Antimicrobial Wound Matrix]

00618474000121PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
00618474000114PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
00618474000107PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
00618474000091PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
00618474000084PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
00618474000039PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylene
00618474000435PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethyleneb
00618474000459PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethyleneb
00618474000442uraPly™ Antimicrobial Wound Matrix (fenestrated) consists of a collagen sheet coated with poly

Trademark Results [PuraPly]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PURAPLY
PURAPLY
86512814 4942534 Live/Registered
Organogenesis Inc.
2015-01-23
PURAPLY
PURAPLY
78058906 2637413 Dead/Cancelled
Organogenesis, Inc.
2001-04-17

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