FDA.reportPublic FDA data

AccuMesh

Primary DI
10884521174672
Brand
AccuMesh
Company
Covidien LP
Model
AMPPCO20X
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
10884521174672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452117467210884521174672

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 Diameter8Inch

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
10884521703827Tri-Staple 2.0SIGCIR21MTORVIL2026-08-09
10884521703834Tri-Staple 2.0SIGCIR21XTORVIL2026-08-09
10884521703841Tri-Staple 2.0SIGCIR25MTORVIL2026-08-09
10884521703858Tri-Staple 2.0SIGCIR25XTORVIL2026-08-09
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26

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