NEOVEIL NV-ET-M60E-3

GUDID 04973077713776

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.

GUNZE LIMITED

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 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 Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 04973077713776
• NIH Device Record Key: a20c82dc-53aa-4645-924e-6be68dcdcf61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEOVEIL
• Version Model Number: NV-ET-M60E-3
• Catalog Number: NV-ET-M60E-3
• 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: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 Millimeter
• Length: 60 Millimeter
• Width: 17 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	04973077713776 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221487

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: 2023-04-04
• Device Publish Date: 2023-03-27

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