| Primary Device ID | 00810157313331 |
| NIH Device Record Key | 9af6ea4a-3c26-41c2-86c3-26d7f1885713 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NizPlant Insertion Tool |
| Version Model Number | NPIT-L |
| Catalog Number | NPIT-L |
| Company DUNS | 118698566 |
| Company Name | Paragon Implant Mfg., LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com | |
| Phone | 1-855-649-4365 |
| info@paragon-implant.com |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Outer Diameter | 3.8 Millimeter |
| Length | 23 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810157313331 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
[00810157313331]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-23 |
| Device Publish Date | 2026-02-13 |
| 00810157313775 | NizPlant Insertion Tool, Short, 19mmL |
| 00810157313331 | NizPlant Insertion Tool, Long, 23mmL |