Primary Device ID | 03760154008181 |
NIH Device Record Key | 43129075-faf2-47e5-a824-59f6212d2802 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OTIS-F |
Version Model Number | OTIS-F AO Ø 6.5 mm tap |
Catalog Number | EVO90T8086 |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03760154008181 [Primary] |
HWX | Tap, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
[03760154008181]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-28 |
Device Publish Date | 2024-06-20 |
03760154009485 | OTIS-F cleaning and sterilization basket. |
03760154009492 | Complete instrumentation tray composed of reusable surgical instruments intended to be used for |
03760154008181 | AO Ø 6.5 mm tap |
03760154008174 | AO drill guide |
03760154008167 | Handle for the OTIS-F AO drill guide |