NEOVEIL NV-L-015G

GUDID 04548366322481

As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. 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 Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2).

GUNZE LIMITED

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID04548366322481
NIH Device Record Keye3602f4e-fa9d-4b17-9c72-20087706b946
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEOVEIL
Version Model NumberNV-L-015G
Catalog NumberNV-L-015G
Company DUNS694678546
Company NameGUNZE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter
Width100 Millimeter
Length100 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104548366322481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OXCMesh, Surgical, Absorbable, Staple Line Reinforcement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-12
Device Publish Date2019-11-04

On-Brand Devices [NEOVEIL]

04548366322481As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbabl
04547301462558As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbabl
04547301462534As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbabl
04973077713783As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbabl
04973077713776NEOVEIL Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic

Trademark Results [NEOVEIL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEOVEIL
NEOVEIL
85830084 not registered Dead/Abandoned
GUNZE LIMITED
2013-01-23
NEOVEIL
NEOVEIL
79129550 4445798 Live/Registered
GUNZE LIMITED
2013-02-08

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