Primary Device ID | 03760154008112 |
NIH Device Record Key | f0e4d599-b76a-42f9-9f62-8aa9113bbb4d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OTIS-C-PLUS & OTIS-F |
Version Model Number | Drill guide |
Catalog Number | EVO9069430 |
Company DUNS | 772462123 |
Company Name | S.B.M |
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 | 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 |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Outer Diameter | 4.5 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03760154008112 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
[03760154008112]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-28 |
Device Publish Date | 2023-12-20 |
03760154002486 - LIGAFIX | 2023-12-29 Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X5 to be used with LIGAFIX interference screws for ACL reconstruction. |
03760154002493 - LIGAFIX | 2023-12-29 Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X10 to be used with LIGAFIX interference screws for ACL reconstruction. |
03760154002561 - LIGAFIX | 2023-12-29 Rigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X5, for ACL reconstruction. |
03760154002578 - LIGAFIX | 2023-12-29 Rigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X10, for ACL reconstruction. |
03760154002608 - LIGAFIX | 2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X5, for ACL reconstruction. |
03760154002615 - LIGAFIX | 2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X10, for ACL reconstruction. |
03760154002622 - LIGAFIX | 2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X1, for ACL reconstruction. |
03760154002639 - LIGAFIX | 2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X5, for ACL reconstruction. |