FDA.reportPublic FDA data

AceConnex™

Primary DI
00810053078655
Brand
AceConnex™
Company
ALLOSOURCE
Model
PSF141060-5
Catalog number
PSF141060-5
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
00810053078655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810053078655008100530786558100530786550810053078655

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
Length60Millimeter
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
M536900380011AlloFuse®90038001900380012015-09-24
M536900380021AlloFuse®90038002900380022015-09-24
M536900380051AlloFuse®90038005900380052015-09-24
M536900380101AlloFuse®90038010900380102015-09-24
M536901380011AlloFuse®90138001901380012015-09-24
M536901380051AlloFuse®90138005901380052015-09-24
M536901380101AlloFuse®90138010901380102015-09-24
M536902380011AlloFuse® Plus90238001902380012015-09-24
M536902380031AlloFuse® Plus90238003902380032015-09-24
M536902380081AlloFuse® Plus90238008902380082015-09-24
M536903380051AlloFuse® Plus90338005903380052015-09-24
M536903380101AlloFuse® Plus90338010903380102015-09-24
M536ABS2001011STIMUBLAST®ABS-2001-01ABS-2001-012015-09-24
M536ABS2001021STIMUBLAST®ABS-2001-02ABS-2001-022015-09-24
M536ABS2001051STIMUBLAST®ABS-2001-05ABS-2001-052015-09-24
M536ABS2001101STIMUBLAST®ABS-2001-10ABS-2001-102015-09-24
M536ABS2002011STIMUBLAST®ABS-2002-01ABS-2002-012015-09-24
M536ABS2002051STIMUBLAST®ABS-2002-05ABS-2002-052015-09-24
M536ABS2002101STIMUBLAST®ABS-2002-10ABS-2002-102015-09-24
M536ABS2003051STIMUBLAST®ABS-2003-05ABS-2003-052015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810129094503InSet Subscap Repair KitThreadstone LLCGAT2026-10-16
20845854655501Argo KnotlessConmed CorporationGAT2026-09-25
20845854655518Argo KnotlessConmed CorporationGAT2026-09-25
14026704420305DEKNATELTELEFLEX INCORPORATEDGAT2026-09-21
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