FDA.reportPublic FDA data

AceConnex™

Primary DI
00810053078693
Brand
AceConnex™
Company
ALLOSOURCE
Model
PSF141140-5
Catalog number
PSF141140-5
Device description
AceConnex™ Pre-Sutured Fascia
Published
2023-11-08
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
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213046000AceConnex Pre-Sutured FasciaAllosource2023-06-27GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810053078693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810053078693008100530786938100530786930810053078693

GMDN Terms#

Term, Definition table
TermDefinition
Cadaveric-donor fascia allograftAn implantable device consisting of fascial tissue (fascia lata) intended for transplantation from a deceased human donor to a genetically different human recipient. It is intended to repair, replace or reinforce structural soft tissue/connective tissue to facilitate wound healing, including repair of dura, eyelid or dental defects.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length140Millimeter
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
946808136
Device count
1
HCT/P
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M536PST17070ReConnex™PST17070PST170702018-08-15
M536PST17075ReConnex™PST17075PST170752018-08-15
M536PST17080ReConnex™PST17080PST170802018-08-15
M536PST17085ReConnex™PST17085PST170852018-08-15
M536PST17090ReConnex™PST17090PST170902018-08-15
M536PST17095ReConnex™PST17095PST170952018-08-15
M536PST17100ReConnex™PST17100PST171002018-08-15
M536PST17105ReConnex™PST17105PST171052018-08-15
M536PST17110ReConnex™PST17110PST171102018-08-15
M536PST17115ReConnex™PST17115PST171152018-08-15
M536PST17120ReConnex™PST17120PST171202018-08-15
M536PST17125ReConnex™PST17125PST171252018-08-15
M536PST17130ReConnex™PST17130PST171302018-08-15
00810053078655AceConnex™PSF141060-5PSF141060-52023-11-08
00810053078662AceConnex™PSF141060-6PSF141060-62023-11-08
00810053078679AceConnex™PSF141100-5PSF141100-52023-11-08
00810053078686AceConnex™PSF141100-6PSF141100-62023-11-08
00810053078709AceConnex™PSF141140-6PSF141140-62023-11-08
M536900380011AlloFuse® 90038001900380012015-09-24
M536900380021AlloFuse®90038002900380022015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899258654799Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654805Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654812Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654829Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258657141Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665764Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665771Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665795Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665863Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665870Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665894Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665962Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258665986Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697864Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697871Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697888Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697895Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258697901Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698038Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698045Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698052Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698069Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698076Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698083Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698090Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698106Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698113Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698120Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698137Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258698144Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27