Primary Device ID | 03760154006279 |
NIH Device Record Key | b60cff94-d439-414a-a137-01757575fd6c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OTIS-C-PLUS |
Version Model Number | Cleaning and sterilization basket |
Catalog Number | EVO90FA700 |
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 | 03760154006279 [Primary] |
FSM | Tray, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
[03760154006279]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-29 |
Device Publish Date | 2023-12-21 |
03760154001052 | Screwdriver for use with OTIS-C-PLUS osteosynthesis plates and associated OTIS screws for HTO. |
03760154001045 | Drill bit for use with OTIS-C-PLUS osteosynthesis plates for HTO. |
03760154001038 | Drill bit for use with OTIS-C-PLUS osteosynthesis plates for HTO. |
03760154001014 | Drill guide for use with OTIS-C-PLUS osteosynthesis plates for HTO. |
03760154006279 | OTIS-C-PLUS cleaning and sterilization basket. |
03760154006248 | OTIS-C-PLUS® countersink bit |
03760154006224 | OTIS-C-PLUS Ø 3 mm drill bit for temporary screw |
03760154008150 | Complete instrumentation set composed of reusable surgical instruments intended to be used for h |
03760154001069 | Depth gauge for HTO. |