FDA.reportPublic FDA data

InnovaBurn

Primary DI
00850002643305
Brand
InnovaBurn
Company
Triad Life Sciences, Inc.
Model
IMB-1020-01
Catalog number
IMB-1020-01
Device description
10cm x 20cm Placental ECM
Published
2022-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213716000InnovaBurnTriad Life Sciences, Inc.2022-09-29KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002643305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002643305008500026433058500026433050850002643305

GMDN Terms#

Term, Definition table
TermDefinition
Wound compression dressingA sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.

Regulatory Flags#

DUNS number
081037338
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002643411InnovaMatrix ACIMX-18MM-012025-01-09
00850002643428InnovaMatrix ACIMX-0203-012025-01-09
00850002643435InnovaMatrix ACIMX-0304-012025-01-09
00850002643442InnovaBurnIMB-0606-012025-01-09
00850002643459InnovaBurnIMB-0707-012025-01-09
00850002643466InnovaBurnIMB-0810-012025-01-09
00850002643473InnovaBurnIMB-1012-012025-01-09
00850002643480InnovaMatrix FSIMF-0203-012025-01-09
00850002643497InnovaMatrix FSIMF-0304-012025-01-09
00850002643503InnovaMatrix FSIMF-0406-012025-01-09
00850002643268InnovaBurnIMB-0505-01IMB-0505-012022-12-21
00850002643275InnovaBurnIMB-0507-01OMB-0507-012022-12-21
00850002643282InnovaBurnIMB-0808-01IMB-0808-012022-12-21
00850002643299InnovaBurnIMB-1010-01IMB-1010-012022-12-21
00850002643312InnovaBurnIMB-1520-01IMB-1520-012022-12-21
00850002643367InnovaMatrix PDIMP-0050-01IMP-0050-012022-12-21
00850002643374InnovaMatrix PDIMP-0100-01IMP-0100-012022-12-21
00850002643398InnovaMatrix PDIMP-0250-01IMP-0250-012022-12-21
00850002643404InnovaMatrix PDIMP-0500-01IMP-0500-012022-12-21
00850002643336InnovaMatrix FSIMF-0202-01IMF-0202-012022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632656OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632663OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632670OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632687OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632694OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632700OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632717OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632724OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632731OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632748OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632755OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632762OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
09421908222515Myriad Meshed Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-07-04
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-06-08
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02