DURAFORM

Primary DI
00382830048873
Brand
DURAFORM
Company
NATUS MEDICAL INCORPORATED
Model
NT801472US
Catalog number
NT801472US
Device description
Dural Graft Implant 1”x 1” (2.54cm x 2.54cm)
Published
2019-06-28
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
GXQDura Substitute

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXQDura SubstituteNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152481000DURAFORM Dural Graft ImplantCodman & Shurtleff, Inc.2015-10-30GXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830056267PackageGS15In Commercial Distribution
00382830048873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830056267003828300562673828300562670382830056267
00382830048873003828300488733828300488730382830048873

GMDN Terms#

Term, Definition table
TermDefinition
Dura mater biomatrix implantA sterile device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). The device is typically in the form of a transparent foil that usually requires no suturing and may be used with fibrin sealant.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-356-0007Madison.Helpdesk@Natus.com

Regulatory Flags#

DUNS number
081325959
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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