XTRASORB® DUP86586

GUDID 00809958186626

Borderless Gentle Tack Super Absorbent Dressing

Derma Sciences Canada Inc

Exudate-absorbent dressing, non-gel Exudate-absorbent dressing, non-gel Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial
Primary Device ID00809958186626
NIH Device Record Key93e6124d-5f94-4e67-885d-aa33de8fc330
Commercial Distribution StatusIn Commercial Distribution
Brand NameXTRASORB®
Version Model Number86586
Catalog NumberDUP86586
Company DUNS200564891
Company NameDerma Sciences Canada Inc
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch
Length15 Centimeter
Width8.6 Inch
Width22 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length6 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Sterility guanteed in unopened, undamaged pouch
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100809958186602 [Unit of Use]
GS100809958186619 [Primary]
GS100809958186626 [Package]
Contains: 00809958186619
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

NACDressing, wound, hydrophilic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-12-07
Device Publish Date2018-08-31

On-Brand Devices [XTRASORB®]

00809958186923Bordered Gentle Tack Super Absorbent Dressing
00809958186824Bordered Gentle Tack Super Absorbent Dressing
00809958186725Bordered Gentle Tack Super Absorbent Dressing
00809958186626Borderless Gentle Tack Super Absorbent Dressing
00809958186527Borderless Gentle Tack Super Absorbent Dressing
00809958186428Borderless Gentle Tack Super Absorbent Dressing
00809958185322Super Absorbent Dressing
00809958184523Super Absorbent HYROGEL COLLOIDAL SHEET (ADHESIVE)
00809958184424Super Absorbent HYROGEL COLLOIDAL SHEET (ADHESIVE)
00809958184325Super Absorbent HYROGEL COLLOIDAL SHEET
00809958184226Super Absorbent HYROGEL COLLOIDAL SHEET
00809958184127Super Absorbent HYROGEL COLLOIDAL SHEET
00809958183724Super Absorbent Adhesive Foam Dressing
00809958183625Super Absorbent Adhesive Foam Dressing
00809958183526Super Absorbent Adhesive Foam Dressing
00809958183427Super Absorbent Non Adhesive Foam Dressing
00809958183328Super Absorbent Non Adhesive Foam Dressing
00809958183229Super Absorbent Non Adhesive Foam Dressing
00809958182819Super Absorbent Dressing
00809958182727Super Absorbent Dressing
00809958182628Super Absorbent Dressing

Trademark Results [XTRASORB]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XTRASORB
XTRASORB
77549489 3719605 Live/Registered
DERMA SCIENCES, INC.
2008-08-18
XTRASORB
XTRASORB
76423471 2770178 Live/Registered
WORK TOOLS INTERNATIONAL, INC.
2002-06-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.