Primary Device ID | B058SLNT03061 |
NIH Device Record Key | 67076570-a8ce-457a-aaa1-59408024a4e3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lag Guide Pin Placement Aid |
Version Model Number | SLNT0306 |
Catalog Number | SLN-T03-06 |
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 | B058SLNT03061 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
Moist Heat or Steam Sterilization
[B058SLNT03061]
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 |
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B058CCD0915NS1 - Cannulated Compression Device (CCD) System | 2024-07-29 CCD Compression Nut - Neutral (non-sterile) |
B058CCD7516045NS1 - Cannulated Compression Device (CCD) System | 2024-07-29 Cannulated Compression Device - 045mm - 16mm (non-sterile) |
B058CCD7516050NS1 - Cannulated Compression Device (CCD) System | 2024-07-29 Cannulated Compression Device - 050mm - 16mm (non-sterile) |
B058CCD7516055NS1 - Cannulated Compression Device (CCD) System | 2024-07-29 Cannulated Compression Device - 055mm - 16mm (non-sterile) |
B058CCD7516060NS1 - Cannulated Compression Device (CCD) System | 2024-07-29 Cannulated Compression Device - 060mm - 16mm (non-sterile) |
B058CCD7516065NS1 - Cannulated Compression Device (CCD) System | 2024-07-29 Cannulated Compression Device - 065mm - 16mm (non-sterile) |
B058CCD7516070NS1 - Cannulated Compression Device (CCD) System | 2024-07-29 Cannulated Compression Device - 070mm - 16mm (non-sterile) |