NeuroFlex
GUDID 00813954020105
Flexible Collagen Nerve Cuff 5mm (inner diameter) x 2.5cm (length)
COLLAGEN MATRIX, INC.
Nerve guide, bioabsorbable, animal-derived| Primary Device ID | 00813954020105 |
| NIH Device Record Key | 3ee3ec84-b604-43ea-8dd2-95b71ed3ffe7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroFlex |
| Version Model Number | CNCF5025 |
| Company DUNS | 176262442 |
| Company Name | COLLAGEN MATRIX, INC. |
| 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
| Lumen/Inner Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
| Length | 2.5 Centimeter |
| Lumen/Inner Diameter | 5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813954020105 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131541
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-16 |
On-Brand Devices [NeuroFlex]
| 00813954020112 | Flexible Collagen Nerve Cuff 6mm (inner diameter) x 2.5cm (length) |
| 00813954020105 | Flexible Collagen Nerve Cuff 5mm (inner diameter) x 2.5cm (length) |
| 00813954020099 | Flexible Collagen Nerve Cuff 4mm (inner diameter) x 2.5cm (length) |
| 00813954020082 | Flexible Collagen Nerve Cuff 3mm (inner diameter) x 2.5cm (length) |
| 00813954020075 | Flexible Collagen Nerve Cuff 2.5mm (inner diameter) x 2.5cm (length) |
| 00813954020068 | Flexible Collagen Nerve Cuff 2mm (inner diameter) x 2.5cm (length) |
Trademark Results [NeuroFlex]
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