| Primary Device ID | B058SLNT020901 |
| NIH Device Record Key | a904be0b-b374-4497-8c5a-e689ec311e8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Modular Reamer Cutter Head |
| Version Model Number | SLNT02090 |
| Catalog Number | SLN-T02-090 |
| Company DUNS | 945518848 |
| Company Name | Orthopedic Designs North America, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com | |
| Phone | 888-635-8535 |
| support@odi-na.com |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B058SLNT020901 [Primary] |
| HTO | Reamer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
[B058SLNT020901]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-05 |
| Device Publish Date | 2023-06-27 |
| B058SLNT021301 | Modular Reamer Cutter Head, 13mm |
| B058SLNT021251 | Modular Reamer Cutter Head, 12.5mm |
| B058SLNT021201 | Modular Reamer Cutter Head, 12mm |
| B058SLNT021151 | Modular Reamer Cutter Head, 11.5mm |
| B058SLNT021101 | Modular Reamer Cutter Head, 11mm |
| B058SLNT021051 | Modular Reamer Cutter Head, 10.5mm |
| B058SLNT021001 | Modular Reamer Cutter Head, 10mm |
| B058SLNT020951 | Modular Reamer Cutter Head, 9.5mm |
| B058SLNT020901 | Modular Reamer Cutter Head, 9mm |