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

• Primary Device ID: 04548366322481
• NIH Device Record Key: e3602f4e-fa9d-4b17-9c72-20087706b946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEOVEIL
• Version Model Number: NV-L-015G
• Catalog Number: NV-L-015G
• Company DUNS: 694678546
• Company Name: GUNZE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter
• Width: 100 Millimeter
• Length: 100 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548366322481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130997

FDA Product Code

• OXC: Mesh, Surgical, Absorbable, Staple Line Reinforcement

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [NEOVEIL]

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