Primary Device ID | B058SLNT041 |
NIH Device Record Key | 5f51bbb5-2e18-477a-bfe3-865fa73fa39f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ratcheting Axial Handle |
Version Model Number | SLNT04 |
Catalog Number | SLN-T04 |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B058SLNT041 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
[B058SLNT041]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-29 |
Device Publish Date | 2023-06-21 |
B058SLNT041 | Ratcheting Axial Handle |
B058ODIU051 | Ratcheting Axial Handle |
B058ODIT1201 | Ratcheting Axial Handle |