FDA.reportPublic FDA data

AccuMesh

Primary DI
10884521171282
Brand
AccuMesh
Company
Covidien LP
Model
AMPMED
Device description
Articulating Mesh Positioning Device with Medium Frame
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
20884521171289PackageGS13Not in Commercial Distribution
10884521171282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452117128920884521171289
1088452117128210884521171282

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, composite-polymerA partially-bioabsorbable, implantable material (e.g., flat sheet) 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 for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521758803Vascufil8886470311V-22020-07-19
20884521082868VersaStepVS1015052016-09-24
10884521038967ValleylabE250510FRNSB2025-03-27
10884524002880ValleylabE250510FRNSB2025-03-27
10884521039100ValleylabE3310NSB2016-09-24
10884521141117WarmTouch50308902019-02-06
10884521205024Shiley4CN65R2016-09-24
10884521205420Shiley5CN70R2016-09-24
10884521205437Shiley6CN75R2016-09-24
10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
20884521171289AccuMeshCovidien LPORQ2016-09-24