Primary Device ID | B058SLNT021201 |
NIH Device Record Key | 06299286-fcd2-43c3-a4ba-d40a14e4650d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Modular Reamer Cutter Head |
Version Model Number | SLNT02120 |
Catalog Number | SLN-T02-120 |
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 | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Outer Diameter | 12 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B058SLNT021201 [Primary] |
HTO | Reamer |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
Moist Heat or Steam Sterilization
[B058SLNT021201]
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 |