FDA.reportPublic FDA data

XTRASORB®

Primary DI
00809958186626
Brand
XTRASORB®
Company
Derma Sciences Canada Inc
Model
86586
Catalog number
DUP86586
Device description
Borderless Gentle Tack Super Absorbent Dressing
Published
2018-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, wound, hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809958186626PackageGS14In Commercial Distribution
00809958186619PrimaryGS10
00809958186602Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958186626008099581866268099581866260809958186626
00809958186619008099581866198099581866190809958186619
00809958186602008099581866028099581866020809958186602

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gelA sterile wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length6Inch
Length15Centimeter
Width8.6Inch
Width22Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Sterility guanteed in unopened, undamaged pouch
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
200564891
Device count
10
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00809958093108Ducare®9409SDUP9409S2019-03-06
00809958013502Dupress®11903DUP119032018-11-13
00809958013601Dupress®11904DUP119042018-11-13
00809958013809Dupress®11907DUP119072018-10-23
00809958013908Dupress®11908DUP119082018-10-23
00809958080115DuCare®82208DUP822082018-10-23
00809958080214DuCare®82212DUP822122018-10-23
00809958080412DuCare®82312DUP823122018-10-23
00809958080511DuCare®82408DUP824082018-10-23
00809958080610DuCare®82412DUP824122018-10-23
00809958080719DuCare®82812DUP828122018-10-23
00809958080818DuCare®82815DUP828152018-10-23
00809958082010DuCare®82910DUP829102018-10-23
00809958084113DuCare®82410DUP824102018-11-20
00809958087411PrimaPad®83338DUP833382018-10-23
00809958087510PrimaPad®83334DUP833342018-10-23
00809958087619PrimaPad®83323DUP833232018-10-23
00809958090510DuCare®90208DUP902082018-11-13
00809958090619DuCare®90212DUP902122018-11-13
00809958090718DuCare®90308DUP903082018-11-13

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Primary DI, Brand, Company table
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