Primary Device ID | B058CSS7020651 |
NIH Device Record Key | 14f91ede-b786-4c1c-a024-7b7b85bffee2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ODI 7.0mm Cannulated Screw System |
Version Model Number | CSS702065 |
Company DUNS | 945518848 |
Company Name | Orthopedic Designs North America, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 |
Outer Diameter | 7 Millimeter |
Length | 65 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 65 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B058CSS7020651 [Primary] |
HTN | Washer, Bolt Nut |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B058CSS7020651]
Moist Heat or Steam Sterilization
[B058CSS7020651]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-10-22 |
B058CSS7021101 | ODI 7.0mm Cannulated Screw – 7.0mm x 110mm |
B058CSS7021051 | ODI 7.0mm Cannulated Screw – 7.0mm x 105mm |
B058CSS7021001 | ODI 7.0mm Cannulated Screw – 7.0mm x 100mm |
B058CSS7020951 | ODI 7.0mm Cannulated Screw – 7.0mm x 95mm |
B058CSS7020901 | ODI 7.0mm Cannulated Screw – 7.0mm x 90mm |
B058CSS7020851 | ODI 7.0mm Cannulated Screw – 7.0mm x 85mm |
B058CSS7020801 | ODI 7.0mm Cannulated Screw – 7.0mm x 80mm |
B058CSS7020751 | ODI 7.0mm Cannulated Screw – 7.0mm x 75mm |
B058CSS7020701 | ODI 7.0mm Cannulated Screw – 7.0mm x 70mm |
B058CSS7020651 | ODI 7.0mm Cannulated Screw – 7.0mm x 65mm |
B058CSS7020601 | ODI 7.0mm Cannulated Screw – 7.0mm x 60mm |
B058CSS0011371 | Washer |