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