FDA.reportPublic FDA data

INTEGRA Flowable Wound Matrix

Primary DI
M269FWD3011
Brand
INTEGRA Flowable Wound Matrix
Company
Integra Lifesciences Corporation
Model
FWD301
Catalog number
FWD301
Device description
INTEGRA Flowable Wound Matrix is an advanced wound care device comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. The granulated collagen-glycosaminoglycan is hydrated with saline and applied in difficult to access wound sites and tunneled wounds. It provides a scaffold for cellular invasion and cappilary growth. INTEGRA Flowable Wound Matrix is supplied sterile, in single use kits containing one syringe with granular collagen, one empty sterile syringe, one luer lock connector, and one flexible injector.
Published
2015-09-23
Public version status
Update
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
KGNDRESSING, WOUND, COLLAGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072113000INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301Integra Lifesciences Corp.2007-10-10KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780032472PrimaryGS10
M269FWD3011SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003247210381780032472

GMDN Terms#

Term, Definition table
TermDefinition
Wound protein matrix solutionA viscous, proteinaceous substance that is topically applied to a wound bed to provide a temporary (degradable) matrix of structural proteins (animal-derived) for the attachment of native cells, to promote wound healing. It is typically contained within a syringe and applied with an applicator. It is intended as a primary dressing typically for hard-to-heal ulcers (e.g., venous leg ulcers), and is covered with a secondary dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
083171244
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
true
Sterilization required before use
false

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