FDA.reportPublic FDA data

AccuMesh

Primary DI
20884521171289
Brand
AccuMesh
Company
Covidien LP
Model
AMPMED
Catalog number
AMPMED
Device description
Articulating Mesh Positioning Device with Medium Frame
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20884521171289PackageGS13In 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
Abdominal hernia surgical mesh, composite-polymerA 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; it is not intended for extra-abdominal applications and not dedicated to 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.

Storage And Handling#

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

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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