NEOVEIL

Primary DI
04973077713776
Brand
NEOVEIL
Company
GUNZE LIMITED
Model
NV-ET-M60E-3
Catalog number
NV-ET-M60E-3
Device description
NEOVEIL Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid(PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6.
Published
2023-03-27
Public version status
Update
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
OXCMesh, Surgical, Absorbable, Staple Line Reinforcement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXCMesh, Surgical, Absorbable, Staple Line ReinforcementGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221487000NEOVEIL Staple Line ReinforcementGunze Limited2022-08-26OXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04973077713776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04973077713776049730777137764973077713776

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter
Width17Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694678546
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548366322450NEOVEILNV-L-05GNV-L-05G2025-04-21
04548366322467NEOVEILNV-L-04GNV-L-04G2025-04-21
04548366322474NEOVEILNV-L-03GNV-L-03G2025-04-21
04548366322498NEOVEILNV-M-05GNV-M-05G2025-04-21
04548366322504NEOVEILNV-M-04GNV-M-04G2025-04-21
04548366322511NEOVEILNV-M-03GNV-M-03G2025-04-21
04548366322528NEOVEILNV-M-015GNV-M-015G2025-04-21
04548366322535NEOVEILNV-S-04GNV-S-04G2025-04-21
04548366322542NEOVEILNV-S-03GNV-S-03G2025-04-21
04548366322559NEOVEILNV-S-015GNV-S-015G2025-04-21
04548366830313NEOVEILNV-S-05GNV-S-05G2025-04-21
04548366830337NEOVEILNV-LL-015GNV-LL-015G2025-04-21
04973077713783NEOVEILNV-ET-M60L-3NV-ET-M60L-32023-03-27
04547301462534NEOVEILNV-ET-M60A-2NV-ET-M60A-22021-01-06
04547301462558NEOVEILNV-ET-M60E-2NV-ET-M60E-22021-01-06
04548366322481NEOVEILNV-L-015GNV-L-015G2019-11-04
04967162947092TheraGenesis Non-Meshed Bilayer Wound MatrixTG-B120240TG-B1202402020-09-14
04967162947108TheraGenesis Non-Meshed Bilayer Wound MatrixTG-B200240TG-B2002402020-09-14
04967162947115TheraGenesis Non-Meshed Bilayer Wound MatrixTG-B4030TG-B40302020-09-14
04967162947122TheraGenesis Non-Meshed Bilayer Wound MatrixTG-B4060TG-B40602020-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04548366322450NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322467NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322474NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322498NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322504NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322511NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322528NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322535NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322542NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366322559NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366830313NEOVEILGUNZE LIMITEDOXC2025-04-21
04548366830337NEOVEILGUNZE LIMITEDOXC2025-04-21
00851677007140Atlas SSLR Buttress AssemblySTANDARD BARIATRICS, INCOXC2024-07-10
04973077713783NEOVEILGUNZE LIMITEDOXC2023-03-27
10705036023296ECHLEONETHICON ENDO-SURGERY, LLCOXC2021-11-17
20705036023293ECHLEONETHICON ENDO-SURGERY, LLCOXC2021-11-17
04547301462534NEOVEILGUNZE LIMITEDOXC2021-01-06
04547301462558NEOVEILGUNZE LIMITEDOXC2021-01-06
04548366322481NEOVEILGUNZE LIMITEDOXC2019-11-04
00733132644568GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644575GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644582GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644599GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644605GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644612GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644629GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644636GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644643GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644650GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28
00733132644667GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXC2018-09-28