FDA.reportPublic FDA data

AccuMesh

Primary DI
10884521174696
Brand
AccuMesh
Company
Covidien LP
Model
AMPPCO15X
Device description
Mesh Positioning System
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORQMesh, surgical, deployer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORQMesh, Surgical, DeployerGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130782000ACCUMESH DEPLOYMENT SYSTEMCovidien, LLC2013-04-05ORQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521174696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452117469610884521174696

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, composite-polymerA sterile, flat, or three-dimensional (3-D), woven/knitted material made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair/reinforcement applications, and excludes devices designed specifically for diaphragmatic hernia repair. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5.9Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20653405990205BioBrace® RC Delivery SystemConmed CorporationORQ2025-04-11
20653405990212BioBrace® RC Delivery SystemConmed CorporationORQ2025-04-11
30653405990202BioBrace® RC Delivery SystemConmed CorporationORQ2025-04-11
00885556735657Bioinductive Implant with Arthroscopic Delivery System - MediumSmith & Nephew, Inc.ORQ2019-08-20
00885556735664Bioinductive Implant with Arthroscopic Delivery System - LargeSmith & Nephew, Inc.ORQ2019-08-20
00801741161247PhasixDavol Inc.ORQ2019-08-16
00801741161292PhasixDavol Inc.ORQ2019-08-16
00801741161216PhasixDavol Inc.ORQ2019-07-12
00801741161223PhasixDavol Inc.ORQ2019-07-12
00801741161230PhasixDavol Inc.ORQ2019-07-12
00801741161254PhasixDavol Inc.ORQ2019-07-12
00801741161261PhasixDavol Inc.ORQ2019-07-12
00801741161278PhasixDavol Inc.ORQ2019-07-12
00801741161285PhasixDavol Inc.ORQ2019-07-12
00801741161308PhasixDavol Inc.ORQ2019-07-12
00854501006128Bioinductive Implant with Arthroscopic Delivery System - HybridSmith & Nephew, Inc.ORQ2018-01-09
00854501006135Bioinductive Implant with Arthroscopic Delivery System - LargeSmith & Nephew, Inc.ORQ2018-01-09
00854501006142Bioinductive Implant with Arthroscopic Delivery System - MediumSmith & Nephew, Inc.ORQ2018-01-09
00854501006098Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, HybridSmith & Nephew, Inc.ORQ2017-11-28
00801741130977VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741130984VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741130991VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131004VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131011VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131028VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131035VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131042VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131059VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131066VENTRALIGHTDavol Inc.ORQ2017-08-25
10884521171282AccuMeshCovidien LPORQ2016-09-24