NeuraGen® 3D PNGM620
GUDID 10381780266761
NeuraGen Advanced Nerve Guide Matrix 6mm x 2cm
Integra Lifesciences Corporation
Nerve guide, bioabsorbable, animal-derived| Primary Device ID | 10381780266761 |
| NIH Device Record Key | 9004b5fc-71a5-4a13-809a-529ad0b5e3ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuraGen® 3D |
| Version Model Number | PNGM620 |
| Catalog Number | PNGM620 |
| Company DUNS | 083171244 |
| Company Name | Integra Lifesciences Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 2 Centimeter |
| Outer Diameter | 6 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780266761 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163457
FDA Product Code
| JXI | CUFF, NERVE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-02-22 |
| Device Publish Date | 2022-12-15 |
On-Brand Devices [NeuraGen® 3D]
| 10381780266846 | NeuraGen Advanced Nerve Guide Matrix 7mm x 3cm |
| 10381780266839 | NeuraGen Advanced Nerve Guide Matrix 6mm x 3cm |
| 10381780266822 | NeuraGen Advanced Nerve Guide Matrix 5mm x 3cm |
| 10381780266815 | NeuraGen Advanced Nerve Guide Matrix 4mm x 3cm |
| 10381780266808 | NeuraGen Advanced Nerve Guide Matrix 3mm x 3cm |
| 10381780266792 | NeuraGen Advanced Nerve Guide Matrix 2mm x 3cm |
| 10381780266785 | NeuraGen Advanced Nerve Guide Matrix 1.5mm x 3cm |
| 10381780266778 | NeuraGen Advanced Nerve Guide Matrix 7mm x 2cm |
| 10381780266761 | NeuraGen Advanced Nerve Guide Matrix 6mm x 2cm |
| 10381780266754 | NeuraGen Advanced Nerve Guide Matrix 5mm x 2cm |
| 10381780266747 | NeuraGen Advanced Nerve Guide Matrix 4mm x 2cm |
| 10381780266730 | NeuraGen Advanced Nerve Guide Matrix 3mm x 2cm |
| 10381780266716 | NeuraGen Advanced Nerve Guide Matrix 2mm x 2cm |
| 10381780266709 | NeuraGen Advanced Nerve Guide Matrix 1.5mm x 2cm |
Trademark Results [NeuraGen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEURAGEN 77821356 3777747 Live/Registered |
NEURAGEN CORP. 2009-09-07 |
 NEURAGEN 76280520 3009061 Live/Registered |
INTEGRA LIFESCIENCES CORPORATION 2001-07-05 |
 NEURAGEN 76280519 2940377 Live/Registered |
INTEGRA LIFESCIENCES CORPORATION 2001-07-05 |
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